9
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 SensEpil™ 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 SensEpil™ or within 24 hours of using Silk’n SensEpil™. 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 SensEpil™ 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.
Infection
Infection of the skin is exceedingly rare but is still a possible risk following a skin burn or wound caused by Silk’n SensEpil™.
Bruising
Very rarely, use of Silk’n SensEpil™ may cause blue-purple bruising that can last 5 to 10 days. As the bruising fades, there may be a rust-brown
discoloration of the skin (hyperpigmentation) that can be permanent.
8. Possible Side Effects using Silk’n SensEpil™
When used according to the instructions, side effects and complications associated with use of Silk’n SensEpil™ are uncommon. However every cosmetic
procedure, including those designed for home use, involves some 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
Adverse Effect
Likelihood of the Adverse Effect
Stacking or Overlapping of multiple
pulses
on the same skin spot
Minor
Minor Skin Discomfort
Minor
Skin Redness
Minor
Increased Sensitivity of the Skin
Minor
Skin Wounds and Burns
Rare
Scarring
Rare
Pigment Changes
Rare
Excessive Redness and Swelling
Rare
Infection
Negligible
Bruising
Negligible
Summary of Contents for sensepil AS101028A
Page 1: ...1 INSTRUCTIONS FOR USE ...
