Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The New Era Laser is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The New Era Laser is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). There is one model, FG 2000. The main components of proposed device include a handpiece to deliver the laser to the area to be treated, a touchscreen for user interface and system control, an emergency switch to stop the system in case of emergency, a key switch to start the system, a connector for the handpiece, an indicator lamp to indicate the current working state, and a foot switch to activate the laser emission. The proposed system provides 36 working modes, which are six modes for men and six modes for women, with adjustable parameters for different Fitzpatrick skin types.
Summary parsed at:2026-06-01 05:57:59 UTC
Diode Laser Therapy Machine
K182604 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K182604 as a predicate
