degree of risk. Therefore it is important that you understand and accept the risks and complications that can
occur with pulsed light hair removal systems designed for home use.
Adverse Event
Likelihood of the Adverse Event
Minor
Stacking or
Overlapping of
multiple pulses
on the same
skin spot
Minor Skin Discomfort. Although home pulsed light hair removal is generally very well-tolerated, most
users do feel some mild discomfort during use, usually described as being a mild stinging sensation on the
treated skin areas. The stinging sensation usually lasts during the time of the application itself or for a few
minutes thereafter.
Anything beyond this minor discomfort is abnormal and means that either you should not continue to use
Silk'n Flash&Go™ because you are unable to tolerate the hair removal application, or that the energy level
setting is too high.
Skin Redness. Your skin may become red right after using Silk'n Flash&Go™ or within 24 hours of using
Silk'n Flash&Go™. Redness generally clears up within 24 hours. See your doctor if redness does not go
away within 2 to 3 days.
Increased Sensitivity of the Skin.The skin of the treated area is more sensitive so you may encounter
dryness or flaking of the skin.
Skin Wounds and Burns. Very rarely, burns or wounds to the skin can occur following the application. The burn
or wound can require a few weeks to heal and, extremely rarely, may leave a noticeable permanent scar.
Scarring. Although very rare, permanent scarring may occur. Usually when scarring occurs, it is in the form
of a flat and white lesion on the skin (hypotrophic).
However, it can be large and red (hypertrophic) or large and extend beyond the margins of the injury
itself (keloid). Subsequent aesthetic treatments may be required to improve the appearance of the scar.
Pigment Changes. Silk'n Flash&Go™ targets the hair shaft, in particular the pigmented cells in the hair
follicle and the hair follicle itself. Nevertheless there is risk of temporary hyperpigmentation (increased
pigment or brown discoloration) or hypopigmentation (whitening) to the surrounding skin. This risk of
changes in skin pigmentation is higher for people with darker skin tones. Usually discoloration or changes
to skin pigment are temporary and permanent hyperpigmentation or hypopigmentation rarely occur.
Excessive Redness and Swelling. In rare cases treated skin may become very red and swollen. This is more
common in sensitive areas of the body. The redness and swelling should subside within 2 to 7 days and
should be treated with frequent applications of ice. Gentle cleansing is OK, but one should avoid exposure
to sun.
10
Adverse Effect
Minor Skin Discomfort
Skin Redness
Increased Sensitivity of the Skin
Skin Wounds and Burns
Scarring
Pigment Changes
Excessive Redness and Swelling
Infection
Bruising
Likelihood of the Adverse Effect
Minor
Minor
Minor
Rare
Rare
Rare
Rare
Negligible
Negligible