Long Term Hair Removal The Flash&Go™ Way - Silk'n Flash&Go User Manual

Adverse Event Likelihood of the
Adverse Event
Stacking or
Overlapping of
Minor
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 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 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 Flash&Go™ or within 24 hours of using 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 scar.
Scarring
Although very rare, 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
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.
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Adverse Effect Likelihood of the
Adverse Effect
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
Usually discoloration or changes to skin pigment are temporary and 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 Flash&Go™.
Bruising
Very rarely, use of Flash&Go™ 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).
9. Long Term Hair Removal the Flash&Go™ Way
A typical full hair growth cycle may take 18-24 months. During this time multiple Flash&Go™ sessions may
be required in order to achieve permanent hair removal.
The efficiency of hair removal varies from person to person according to body area, hair color, and how
Silk'n Flash&Go™ is used.
Typical Silk'n Flash&Go™ hair removal plan during a full hair growth cycle:
Treatments 1-4 – plan two weeks apart
Treatments 5-7 – plan four weeks apart
Treatments 8 + – treat as needed, until desired results are achieved.
Expected Treatment Outcome for Hair Removal
Fitzpatrick Light Fluence Anatomic area
Hair Color
skin type [J/cm 2 ] of the body
Lower or upper legs
Arms
Light brown to
I-IV 3-4.5
brown
Bikini Line
Underarms
Lower or upper legs
Arms
I-IV Brown to black 3-4.5
Bikini Line
Underarms
Average Number of Effectiveness (% of hair
2 Treatments 1 removal/regrowth)
60% Hair reduction
Session 10-12, approx. 50% Hair reduction
four weeks apart. 60% Hair reduction
55% Hair reduction
70% Hair reduction
Session 8-10, approx. 60% Hair reduction
four weeks apart. 70% Hair reduction
65% Hair reduction
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