Manufacturer
Step UP Skin Laser, LLCNew Era
Country / Region:United States (US)Submission type:Traditional
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
- K182604
- Device name
- New Era
- Company
- Step UP Skin Laser, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-09-21
- Decision date
- 2018-11-14
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1Diode Laser Therapy Machine
K182604 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 K182604 as a predicate
