Manufacturer
Beijing Stelle Laser Technology Co., Ltd.Dermatological diode laser system
Beijing Stelle Laser Technology Co., Ltd.
Country / Region:China (CN)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
- K212478
- Device name
- Dermatological diode laser system
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-08-09
- Decision date
- 2022-01-14
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Dermatological diode laser system 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 Dermatological diode laser system 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 Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot-switch. The laser light targets melanin and treats selectively in a precise way. Melanin absorbs the energy from the laser, resulting in a rapid temperature increase that destroys germinal cells without damaging the epidermis and surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells. The four models of different products produced by our company are consistent in Wavelength, Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency, and so on. It's just that the shell is slightly different.
Summary parsed at:2026-06-01 05:38:28 UTC
Predicate devices
1Diode Laser Hair Removal System
K212478 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 K212478 as a predicate
