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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
Mild pain / discomfort in the area being treated
Warm feeling or tingling sensations during
treatment, which typically disappear after a few
seconds to a minute and decrease with continued
use.
Itchiness in the treatment area
Skin redness during or after treatment which
disappears within minutes.
Skin redness which does not disappear within
minutes and lasts 24-48 hours.
Pain or discomfort that is intense during treatment
or persists after a treatment.
In very rare cases
Swelling and redness that does not disappear
within two to three days.
Temporary changes in skin color (lightening or
darkening).
Blistering or burning of the skin.
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.
8
How to assess and react
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.
This is expected and is normal for all IPL
treatments. You can keep on using the device as
instructed.
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.
This is expected and is normal for all IPL
treatments. You can keep on using the device as
instructed once skin redness has disappeared.
Stop using the device immediately and consult
your physician before using it again.
Stop using the device immediately and consult
your physician before using it again.
How to assess and react
Stop using the device immediately and consult
your physician before using it again.
If your skin color changes, stop using the device
immediately and consult your physician.
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.
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