Diode Laser Hair Removal System

Shandong Huamei 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

Predicate devices

2

Cited as predicate

10

Device details

FDA 510(k) registration fields

K number
K162659
Device name
Diode Laser Hair Removal System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-09-26
Decision date
2017-06-16
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 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 Hair Removal 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 Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The device includes a control panel that uses a microcontroller and an LCD screen for human-machine interaction, a main control module that manages laser energy parameters and system state, a constant current board module for driving the semiconductor laser, a temperature and humidity control system, and a handpiece module that executes the laser emission function.

Summary parsed at:2026-06-01 05:58:57 UTC

Predicate devices

2

K162659 references 2 predicate/reference devices

Cited as predicate

10

10 submissions cite K162659 as a predicate