Manufacturer
Beijing Winkonlaser Technology LimitedDiode Laser Hair Removal System
Beijing Winkonlaser Technology Limited
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
- K241860
- Device name
- Diode Laser Hair Removal System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-27
- Decision date
- 2024-09-25
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Diode Laser Hair Removal 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 Diode Laser Hair Removal 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 Diode Laser Hair Removal System utilizes an 808nm diode laser using selective light absorption, preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, with minimal energy transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around the hair follicle, thereby reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect it. The device adopts a Gold standard 808nm semi-conductor laser, based on the principle of selective photothermolysis, where the specific wavelength penetrates the epidermis into the dermis, and the optical energy is absorbed and translated into heat energy that restrains hair follicle tissues, producing a photothermal effect. It effectively targets hair follicles rich in melanin while surrounding tissues absorb less or no energy, achieving hair removal without harming adjacent tissues and providing a virtually pain-free experience.
Summary parsed at:2026-06-01 05:28:50 UTC
Predicate devices
1Medical Diode Laser Hair Removal System
K241860 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 K241860 as a predicate
