Medical Diode Laser Hair Removal System

Weifang Mingliang Electronics 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

Predicate devices

2

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K200525
Device name
Medical Diode Laser Hair Removal System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-03-02
Decision date
2020-05-27
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Intended Use

The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Device Description

Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through an LCD touch-screen. In the handpiece of the machine, the light emitted by each discharge at 808nm.

Summary parsed at:2026-06-01 05:47:52 UTC

Predicate devices

2

K200525 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K200525 as a predicate