Manufacturer
Guangzhou Chuang Zao Mei Technology Co., Ltd.Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
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
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243465
- Device name
- Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-11-08
- Decision date
- 2025-02-06
- 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, GENESIS, Lotus and Ultimate) 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, GENESIS, Lotus and Ultimate) 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 and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five 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), GENESIS (1-74 J/cm²), Lotus (1-67 J/cm²), and Ultimate (1-65 J/cm²). Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.
Summary parsed at:2026-06-01 05:21:38 UTC
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