Manufacturer
Lumenis Be, Ltd.FoLix
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242349
- Device name
- FoLix
- Company
- Lumenis Be, Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-08-08
- Decision date
- 2024-09-09
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The FoLix System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
Intended Use
The FoLix System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
Device Description
The FoLixTM is a laser system intended to be used for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV seeking treatment for hair loss.
Summary parsed at:2026-06-01 05:29:21 UTC
Predicate devices
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Not ingested
K242349 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242349 as a predicate