Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
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
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K242349 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K242349 as a predicate
