Manufacturer
Epilady 2000, LLCEpilaser
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K170970
- Device name
- Epilaser
- Company
- Epilady 2000, LLC
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-03-31
- Decision date
- 2017-09-01
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Intended Use
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
Summary parsed at:2026-06-01 06:00:05 UTC
Predicate devices
2Cited as predicate
1Epilaser Pro
1 submission cite K170970 as a predicate
