Manufacturer
Guangzhou Chuang Zao Mei Technology Co., Ltd.Diode Laser Hair Removal Device
Guangzhou Chuang Zao Mei 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
- K221312
- Device name
- Diode Laser Hair Removal Device
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-05-05
- Decision date
- 2022-06-29
- 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 Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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 Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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 Device is a surgical device intended for use in dermatologic and general surgical procedures. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch. There are two models included, EVOLUTION MEDICAL, M-I-X MEDICAL, the two models have the same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm2), M-I-X MEDICAL (1-70 J/cm2).
Summary parsed at:2026-06-01 05:40:01 UTC
Predicate devices
1Dermatological Diode Laser Systems
K221312 references 1 predicate/reference device
Cited as predicate
3US 450 Diode Laser Equipment
Diode laser Treatment System (K18)
Medical Diode Laser Hair Removal System (MNLT-D1)
3 submissions cite K221312 as a predicate
