Laser Hair Growth System
(ML200/160/120/88)
USER MANUAL
TABLE OF CONTENTS
1. Product Introduction.........................................................................................................................................................4
· 1.1 Product Name ............................................................................................................................................................ 4
· 1.2 Model & Specifications ............................................................................................................................................ 4
·
1.3 Structure Composition
............................................................................................................................................. 4
· 1.4 How the product works ........................................................................................................................................... 4
·
1.5 Intended Use(Indications Of Use)
.......................................................................................................................... 4
· 1.6 Expected effect............................................................................................................................................................. 5
·
1.7 Contraindications:
.........................................................................................................................................................5
·
1.8 Precautions
...................................................................................................................................................................5
·
1.9 Safety Warnings
.......................................................................................................................................................... 6
·
1.10 Explanation of Product Symbols
...............................................................................................................................7
·
1.11 UDI information
..........................................................................................................................................................7
·
1.12 product life
..................................................................................................................................................................7
2.Product Property
................................................................................................................................................................. 8
·
2.1 Usage environment
................................................................................................................................................... 8
· 2.1.1 Transportation and storage environment ..............................................8
· 2.1.2 Operating Environment .............................................................. 8
· 2.2 Product Classification................................................................................................................................................... 8
·
2.3 Technical Specifications
............................................................................................................................................... 8
· 2.4 Power Supply Conditions............................................................................................................................................ 8
3.Product Structure
................................................................................................................................................................ 9
4.Operation Instructions
........................................................................................................................................................9
·
4.1 Software Download
................................................................................................................................................... 11
· 4.2 APP Operation........................................................................................................................................................... 11
· 4.3 Charging & Indication............................................................................................................................................... 11
· 4.4 Software Version........................................................................................................................................................12
· 4.5 Network Functions.....................................................................................................................................................12
5. Maintenance inspection ................................................................................................................................................. 12
· 5.1 Cleaning and maintenance....................................................................................................................................... 12
5.2 Preventive inspection....................................................................................................................................................... 13
6. Common Faults and Solutions
......................................................................................................................................13
7. Afer-Sales Service
............................................................................................................................................................ 14
8. Manufacturer
.................................................................................................................................................................... 14
9. Instructions for Use Information
...................................................................................................................................14
10.Packing List ...................................................................................................................................................................... 14
Electromagnetic Compatibility Guidelines and Manufacturer's Declaration ........................................................... 14
FCC Requirement ..............................................................................................................................................................18
Adverse Event Reporting: To report adverse events, visit the FDA MedWatch website
(https://www.fda.gov/safety/medwatch) or call the reporting number 1-888-463-6332
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肤色分级
1. Product Introduction
· 1.1 Product Name
Laser Hair Growth System
·
1.2 Model & Specifications
Model
Working Time
Temperature Data
Start-up Method
Number of Laser Lights
ML200
30min
Yes
Connect and start via
the mobile app
200
ML160
30min
Yes
Connect and start via
the mobile app
160
ML120
30min
Yes
Connect and start via
the mobile app
120
ML88
30min
Yes
Connect and start via
the mobile app
88
· 1.3 Structure Composition
The laser hair growth System consists of a hair growth device, 650nm laser diodes, a USB power cable, and
a mobile application software.
· 1.4 How the product works
The Laser Hair Growth System irradiates the scalp with red light of approximately 650nm wavelength,
stimulating the mitochondria of hair follicle cells to enhance mitochondrial respiration.
· 1.5 Intended Use(Indications Of Use)
The Laser Hair Growth System is indicated to treat androgenetic alopecia for men and women. It is
designed to promote hair growth in males who have Norwood-Hamilton Classifications Ⅱa to V
and in females who have Ludwig-Savin scale Classifications Ⅰ to Ⅱ. All users should also have
Fitzpatrick Skin Types Ⅰ to Ⅳ.
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·
1.6 Expected effect
Take once every other day for 30 minutes per session，do not exceed the time limit. Complete 16
weeks of treatment, with results varying by individual.
· 1.7 Contraindications
WARNING: Do not use on individuals with photosensitivity disorders
WARNING: Do not use on individuals with active skin infections or inflammation
WARNING: Do not use on individuals with a history of skin cancer
WARNING: Do not use on individuals with implanted electronic devices (pacemakers, defibrillators,
etc.)
·
1.8 Precautions
Note:
Thank you for choosing and purchasing this product!
To ensure safe and effective use, please read this user manual carefully and operate the device strictly in
accordance with the instructions. The images shown in this manual are for reference only; actual product
appearance and color may vary.
This manual is compiled by our company, and we reserve the final right of interpretation.
Laser Safety Precautions:
Never point the laser directly into the eyes, as this may cause eye injury.
Using mirrors or optical devices to observe the laser beam increases the risk of eye damage.
General Safety Precautions:
This device does not generate strong electromagnetic waves during operation. However, to avoid
potential interference, it is recommended to avoid using it simultaneously with other high-sensitivity
electronic equipment.
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Do not use on broken or irritated skin.
This device is not intended as a safety helmet or head protection device.
Avoid dropping or subjecting it to severe impact.
Keep away from direct sunlight and corrosive gases.
Store out of reach of children and pets.
Do not use the device when your hair is wet.
Do not drop objects into or insert anything into the ventilation openings or slots. Prevent insects or
small animals from entering the device.
The laser module is sensitive to electrostatic discharge (ESD). Do not expose the bottom of the device
to static electricity or other high-voltage sources.
When storing the device for extended periods, keep it in the specified storage environment. Charge
the battery at least once per month to maintain optimal battery performance.
Overuse or underuse of the device may reduce hair growth effectiveness.
During use, scalp temperature may rise slightly. Under normal conditions, this will not cause burns. If
you experience discomfort due to excessive heat, discontinue use immediately.
For greater comfort, we recommend using the device in an air-conditioned environment.
Use only original manufacturer components. Internal repairs should be performed exclusively by
qualified technicians.
Intended for individual use only — do not share among multiple users.
Before first use, fully charge the device.
Avoid charging in environments exceeding 45°C.
The internal rechargeable lithium battery must never be disassembled, impacted, punctured, or
exposed to fire, as this may cause explosion. Avoid short-circuiting the battery terminals to prevent
damage. Use only chargers compliant with IEC 60601-1 standard (Output: DC 5V⎓ 2A).
If the internal lithium battery shows signs of deformation, leakage, or other abnormalities, stop using
the device immediately to prevent accidents.
Used batteries may harm the environment — please dispose of them through proper recycling
channels.
·
1.9 Safety Warnings
Warning:
Do not use this device while bathing or showering!
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Do not use this product near bathtubs, showers, sinks, or other water-containing vessels!
The Laser Hair Growth Device emits intense visible light. During use, strictly follow the operating instructions
for treatment!
Always protect your eyes during treatment! Never look directly into the laser beam output port! Do not stare
at or view the beam directly through optical instruments (e.g., mirrors, magnifiers, cameras) — this may cause
permanent eye damage or vision impairment!
During treatment, do not observe the laser tube’s operation by looking through the edges of the
device.Patients must wear the device correctly — do not position the center of the device on the forehead.
Do not replace any components without prior written authorization from the manufacturer!
This device is NOT intended for use on skin types Fitzpatrick Ⅴ–Ⅵ！
·
1.10 Explanation of Product Symbols
Warning: Do not look directly at Class 3R laser products
laser window
Radiation output and standard specifications
BF Application Section
Level of protection against liquid ingress
Class II equipment
General warning symbols
Follow the operating instructions
Manufacturer
Serial number
Date of manufacture
Unique device identifier
Keep dry
· 1.11 UDI information
See the label on the product or its packaging.
· 1.12 product life
Shelf life:5 years(from the date of manufacture)
Service life: 3 years
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2.Product Property
·
2.1 Usage environment
· 2.1.1 Transportation and storage environment
Ambient temperature: -20℃~55℃
Relative humidity range: ≤93%RH, non-condensing
Atmospheric pressure range: 70.0~106.0kPa
·
2.1.2 Operating Environment
Ambient temperature: 5℃~40℃
Relative humidity range: 45%-75%RH
Atmospheric pressure range: 86.0~106.0kPa
Heat engine time: If transported or stored outside the operating temperature range, let the equipment be at
room temperature for 2 hours before use
·
2.2 Product Classification
Classification by type of protection against electric shock: Internal power supply equipment
Classified by the degree of electric shock protection: BF type
Classification by liquid ingress protection rating: IP22
Safety classification for use with air-mixed flammable anesthetic gases or with air-mixed flammable anesthetic
gases mixed with oxygen or nitrous oxide: equipment not to be used with air-mixed flammable anesthetic
gases or with air-mixed flammable anesthetic gases mixed with oxygen or nitrous oxide
By operation mode: Continuous operation
Whether or not the device has signal output or input parts: Not applicable
Permanent installation equipment or non-permanent installation equipment: Non-permanent installation
equipment
Applicable to applications requiring protection against defibrillation discharge effects: Not applicable
· 2.3 Technical Specifications
Laser Parameters:
Light source type: Class 3R laser, visible light
Peak wavelength: 650nm±10nm
Pulse width: 60ms±2ms
Pulse frequency: 6.94Hz±0.50Hz
Laser output power: 5mW/each, error ±20%
Output power instability: <10%
Light output power uniformity: ±20%
Performance Parameters:
Working noise: ≤65dB (A)
Surface temperature of the light radiation output window: ≤50℃ (ambient temperature 40℃)
Software Specifications:
Software version: V1
Operating system compatibility: iOS 13.0+, Android 10.0+
Bluetooth version: Bluetooth 5.0
Data storage capacity: 50MB
· 2.4 Power Supply Conditions
Battery Specifications:
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Power Supply: Lithium battery (3.7V, 3500mAh)
Battery type: Li-ion, rechargeable
Battery capacity: 3500mAh
Charging voltage: 5V DC
External Power Supply:
Type-C Input: 5V⎓ 2A
This product does not include an AC adapter.
Please select a Type C adapter.
We recommend using an adapter that meets the following specifications:
Input: 100~240V 50/60HZ
Output: 5V⎓ 2A
Implementation standard: IEC 60601-1:2020
3.Product Structure
1.
Power Button
2.
Power/Bluetooth indicator
3.
USB charging port
4.
Post-silicone sheath
5.
Right pad
6.
Left pad
7.
Pre-silicone sheath
8.
Laser head
9.
Safety protection switches
Key Safety Features:
Multiple safety interlock switches
Laser emission only when properly worn
Low battery protection
4.Operation Instructions
1.
The user activates the device for laser therapy, with a daily dose administered every other day.
2.
Press and hold the power switch to trigger the buzzer with a long 'beep' sound.
3.
Connect the laser hair growth device via Bluetooth through the mobile app.
4.
After successful connection, place the laser hair growth device on your head. Select the appropriate mode in
the app, then send the activation command. The device will activate automatically upon receiving the
command, and you can start using it.
5.
The laser will begin irradiation with a 30-minute countdown.
6.
After treatment, the device emits three short beeps before automatically shutting down.
7.
To manually shut down the device without charging, hold any mode button for more than 1 second.
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8.
The device will automatically shut down after 3 minutes of inactivity (either without Bluetooth connection or if
no operation is performed after connecting).
9.
If the cap is removed during treatment, the light will pause. If the cap is not reinserted within 10 minutes, the
device will automatically shut down
10.
Cleanse your scalp and pat dry your hair before use.
11.
This product features a safety switch. The machine will only operate normally when properly worn on the head.
Operation Diagram
Connect Bluetooth
Start using
Wear hair growth
device
Remove the device at the end
Select area
Clean hair growth device
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· 4.1 Software Download
Search for “Laser Hair Growth” in the App Store on iOS and Google play on Android to download and install the
APP.
Software Requirements:
1. Minimum iOS version: iOS 13.0
2. Minimum Android version: Android 10.0
3. Required permissions: Bluetooth, Location, read the device serial number (SN)
4. Data storage capacity: 50MB
· 4.2 APP Operation
Step-by-Step Operation:
1. Open the APP, add a device on the “Device” page.
2. After adding the device, when the laser generator is on, open the Bluetooth connection to the generator on the
mobile phone.
3. Click the generator icon in the APP interface to enter the device working page. At this time, the working status is
“connected”, and you can choose the appropriate working mode.
4. Wear the hair growth device, select the working mode, and the laser will start to irradiate. At this time, the
working state is “working”, and the countdown of 30 minutes will be displayed.
5. When entering the device working page, the working status is “Not connected”, please turn on the mobile phone
Bluetooth to connect.
6. If the hat is removed during the treatment, the light will be paused. The working state will be “paused”, Please put
the hat back on and continue the light within 10 minutes.
7. APP has voice prompt function.
Safety Confirmation Steps:
User must confirm understanding of contraindications
· 4.3 Charging & Indication
Charging Instructions:
1. Please charge fully before the first use.
2. The charging port is located at the back of the product. Plug in the charging cable, connect the charger and
power supply, and start charging.
3. When charging, the green light around the switch will flash, and the green light will stay on when fully charged.
All modes will not work in charging state.
Battery Status Indicators:
1. Green light flashing: Charging in progress
2. Green light steady: Fully charged
3. Green light flashing rapidly: Low battery (needs charging)
4. Green light flash rapidly for 5 times and then the product automatically shut down: Battery power is insufficient
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5. Blue light flashing: Bluetooth connecting
6. Blue light steady: Bluetooth connected
· 4.4 Software Version
APP software version: V1
Embedded firmware version: V1
· 4.5 Network Functions
Bluetooth version: 5.0
Bluetooth signal strength: 0dBm
5. Maintenance inspection
·
5.1 Cleaning and maintenance
Clean the surface of the instrument with a clean soft cloth or cotton ball, dip it in an appropriate
amount of neutral detergent, wring it to the appropriate humidity, and gently wipe it.
Turn off the instrument before cleaning.
Clean the cooling hole at the top of the hair growth device regularly to prevent clogging.
Do not wash the top of the hair growth device directly with liquid.
Clean the silicone parts inside the hair growth device with 70% medical alcohol before and after each
use.
Do not use abrasive cleaners
Note:
The silicone components in contact with the human body have passed ISO 10993 biocompatibility testing,
meeting all relevant standards for skin irritation and cytotoxicity.
Operation Diagram
Turn off the instrument and gently wipe Clean the heat dissipation hole
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Direct liquid pouring on the top is prohibited 70% medical alcohol is used to clean silicone parts
5.2 Preventive inspection
Regular Inspection Schedule:
· Check the inner shell, outer shell and power cord for damage every two weeks
·
Check safety interlock switches monthly
·
Inspect battery performance quarterly
Professional Maintenance:
· Conduct laser power testing at least annually.
· Notify the manufacturer or franchiser to replace the laser if a significant power drop is detected.
6. Common Faults and Solutions
phenomenon
cause
Solution
No laser output
Battery has run out
Charge according to instructions in manual
The hair growth device
is not properly worn
Check the hair growth device and adjust wearing
position
The laser stopped
outputting or restarted
during operation
Low battery
Charge according to Instructions in Manual
questions
Solution
Bluetooth connection lost
during use
The helmet will continue to function normally and shut down after
Bluetooth disconnects.
Use the app to reconnect to Bluetooth.
No Voice
Check if Phone is on Silent Mode, and turn up the phone volume.
During use, the light from
the hair growth device
does not stop after the
The Wearing Detection Device is not working. Contact your local dealer
or sales platform.
70%
alcohol
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Note: 1. Consumers are not allowed to disassemble the device and repair the internal components or parts.
2. If the product is not functioning properly, please contact your local distributor or sales platform.
7. Afer-Sales Service
The warranty period for this product may vary depending on the country of sale, and we will extend it as much as
legally permitted under local laws.
From the date of purchase, the entire product is covered by a one-year warranty under normal use.
If the product develops a fault during the warranty period under normal use and requires free repair, please contact
your local authorized dealer or the sales platform where you purchased the product.
The following situations are not covered by the free warranty:
Damage caused by improper use, maintenance, or storage by the consumer.
Damage resulting from disassembly or modification by unauthorized personnel.
Failure to provide a valid original invoice.
Damage caused by force majeure (e.g., natural disasters, accidents, etc.).
8. Manufacturer
Name: Providence Enterprise(Ganzhou)Co.,Ltd
Address: No.38, Guangming Road, Zhanggong High-Tech Zone, Zhanggong District, Ganzhou, Jiangxi Province, P.R.
China
9. Instructions for Use Information
Version: V1.0
Issue Date: 2025-11-28
10.Packing List
Laser Hair Growth System x1
USB Power Cable x1
User Manual x1
Fabric Storage Bag x1
Electromagnetic Compatibility Guidelines and Manufacturer's Declaration
head is removed
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Note：
· The ML Series Laser Hair Growth System complies with the electromagnetic compatibility requirements of the
IEC 60601-1-2 standard.
· Users shall install and operate the device in accordance with the electromagnetic compatibility information
provided in the accompanying documents.
· Portable and mobile RF communication equipment may affect the performance of the ML Series Laser Hair
Growth System. Avoid strong electromagnetic interference during use, and keep the device away from mobile
phones, microwave ovens, and similar sources.
· During operation, maintain a distance of at least 1 meter from individuals wearing cardiac pacemakers. Avoid
simultaneous use with highly sensitive electronic equipment to prevent mutual interference.
· For detailed guidelines and the manufacturer's declaration, please refer to the appendix.
Warning：
a) The use of cables and other accessory accessories other than those sold as spare parts by the manufacturer
of ML Series Laser Hair Growth System in conjunction with ML Series Laser Hair Growth System may result in
an increase in the electromagnetic emission of ML Series Laser Hair Growth System or a decrease in immunity.
b) ML Series Laser Hair Growth System should not be used in close proximity to or stacked with other devices,
and if it must be used in close proximity or stacked, it should be observed to verify that it can operate
normally under the configuration used.
Essential performance:
During and after EMS (Electromagnetic Susceptibility) tests, the change of parameter numerical values doesn’t
exceed the specified accuracy as below.
Peak wavelength: 650nm±10nm
Laser output power: 5mW/each, error ±20%
This product declarations to meet Table 1, Table 2, Table 3 and Table 4 of Contents.
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Table1
Manufacturer's Declaration - Electromagnetic Emissions
The ML Series Laser Hair Growth System intended for use in the electromagnetic environment specified below.
The customers or users should ensure that it is used in such an environment.
Emission measurement
Conformity
RF emission
CISPR 11
Group 1
RF emission
CISPR 11
Class B
Harmonic emission
IEC 61000-3-2
Class A
voltage fluctuations / flicker emission
IEC 61000-3-3
Applicable
Table 2
Manufacturer's Declaration - Electromagnetic Immunity
The ML Series Laser Hair Growth System intended for use in the electromagnetic environment specified below.
The customers or users should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level guidelines
Compliance level
electrostatic
discharge
IEC 61000-4-2
Contact:± 8 kV.
Air:± 2kV, ±4kV, ±8kV, ± 15 kV
Contact:± 8 kV.
Air:± 2kV, ±4kV, ±8kV, ± 15 kV.
Radiated RF EM
fields
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Electrical fast
transientburst
IEC 61000-4-4
± 2 kV for power supply lines.
± 2 kV for power supply lines.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s).
± 1 kV line(s) to line(s).
Conducted RF
IEC 61000-4-6
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
Power frequency
magnetic field
(50Hz and 60Hz)
IEC 61000-4-8
30A/m
30A/m
Power input line
voltage dips,
short interruptions
and voltage
variations
IEC 61000-4-11
0% U
T
, 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% U
T
, 1 cycle and 70%U
T
,25/30 cycles
Single phase:at 0°
0% U
T
, 250/300 cycles
0% U
T
, 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% U
T
, 1 cycle and 70%U
T
,25/30 cycles
Single phase:at 0°
0% U
T
, 250/300 cycles
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Table 3
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The ML Series Laser Hair Growth System is intended for use in the electromagnetic environment specified below.
The customer or the user of the ML Series Laser Hair Growth System should ensure that it is used in such an
environment.
Test
frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance
LEVEL
(V/m)
385
380-390
TETRA 400
Pulse
modulation
b)
18 Hz
1,8
0,3
27
27
450
430-470
GMRS 460,
FRS 460
FM c)
±5 kHz
deviation
1 kHz sine
2
0,3
28
28
710
704-787
LTE Band 13,
17
Pulse
modulation
b)
217 Hz
0,2
0,3
9
9
745
780
810
800-960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
b)
18 Hz
2
0,3
28
28
870
930
1720
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation
b)
217 Hz
2
0,3
28
28
1845
1970
2450
2400-
2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation
b)
217 Hz
2
0,3
28
28
5240
5100-
5800
WLAN 802.11
a/n
Pulse
modulation
b)
217 Hz
0,2
0,3
9
9
5500
5785
NOTE：If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting
antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is
permitted by IEC 61000-4-3.
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a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while
it does not represent actual modulation, it would be worst case.
Table 4
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields
The ML Series Laser Hair Growth System intended for use in the electromagnetic environment specified below. The
customers or users should ensure that it is used in such an environment.
Test frequency
Modulation
IMMUNITY TEST LEVEL (A/m)
30 kHz
CW
8
1 34,2 kHz
Pulse modulation
b)
2,1 kHz
65
c)
1 3,56 MHz
Pulse modulation
b)
50 kHz
7,5
c)
a) This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME
HEALTHCARE ENVIRONMENT .
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) r.m.s., before modulation is applied.
FCC Requirement
Any changes or modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses, and can
radiate radio frequency energy, and if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
– Consult the dealer or an experienced radio/TV technician for help.
