Manufacturer
Beijing Unt Technology Co., Ltd.Diode laser therapy system
Beijing Unt Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K212978
- Device name
- Diode laser therapy system
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-17
- Decision date
- 2021-11-10
- 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 therapy 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 therapy 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 proposed device, Diode laser therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage. The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black).
Summary parsed at:2026-06-01 05:43:57 UTC
Predicate devices
1Diode Laser Therapy Systems
K212978 references 1 predicate/reference device
Cited as predicate
1Diode Laser Therapy Systems (V19)
1 submission cite K212978 as a predicate