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

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Product code

GEX
21 CFR 878.4810

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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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