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8
groups for this response are females of Mediterranean, Middle Eastern, and South
Asian heritage treated on the face and neck.
DO NOT USE the device on any area where you may want hair to grow back.
The device is not recommended for use on red, grey or blonde hair since it is not
effective on these hair colors.
4 Potential Risks, Side Effects and Skin Reactions
The use of this device could result in side effects. The table below lists the known skin reactions that may
occur following treatment with the device.
Possible Side Effects How to assess and react
Mild pain / discomfort in the area being treated This is expected and is normal for all IPL
treatments. You can keep on using the device as
instructed, and the pain should diminish with
continued use.
Warm feeling or tingling sensations during
treatment, which typically disappear after a few
seconds to a minute and decrease with continued
use.
This is expected and is normal for all IPL
treatments. You can keep on using the device as
instructed.
Itchiness in the treatment area This is quite common for IPL treatments, and
should subside after a short period. You can keep
on using the device as instructed. Do not scratch
the area.
Skin redness during or after treatment which
disappears within minutes.
This is expected and is normal for all IPL
treatments. You can keep on using the device as
instructed once skin redness has disappeared.
Skin redness which does not disappear within
minutes and lasts 24-48 hours.
Stop using the device immediately and consult
your physician before using it again.
Pain or discomfort that is intense during treatment
or persists after a treatment.
Stop using the device immediately and consult
your physician before using it again.
In very rare cases How to assess and react
Swelling and redness that does not disappear
within two to three days.
Stop using the device immediately and consult
your physician before using it again.
Temporary changes in skin color (lightening or
darkening).
If your skin color changes, stop using the device
immediately and consult your physician.
Blistering or burning of the skin. Stop using the device immediately and consult
your physician before using it again. Apply a cold
pack to the area. Treat with antiseptic or burn
cream.
In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The recorded effects were:
• Itchiness: Four subjects experienced mild itchiness after treatment.
• Slight Redness: This was reported by 1 subject.
• Mild Stinging Sensation: Five subjects reported mild discomfort following treatment.
• In-growing Hair: One subject reported experiencing an in-growing hair following treatment.
• Follicle Redness: One subject reported a red spot at the treatment site following treatment.
In all cases, the treated skin returned to normal within 7 days.
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