Diode laser hair removal device

Zhengzhou PZ Laser Slim 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

1

Cited as predicate

7

Device details

FDA 510(k) registration fields

K number
K180353
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
2018-02-08
Decision date
2018-04-17
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 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 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 device, 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, allowing the operator to set device parameters and control the output laser energy. The main control module receives laser energy parameters and work instructions, detects the footswitch state, and monitors temperature, humidity, liquid level, and flow during operation. The constant current board module supplies the semiconductor laser with a constant drive current and includes detection functions for over-current, over-voltage, and over-temperature. The temperature and humidity control system manages the working state of the condenser, cold plate, and cooling fan based on detected parameters. The handpiece module is the execution unit that emits laser light and includes components for temperature and humidity sensing, cooling, and energy output.

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

Predicate devices

1

K180353 references 1 predicate/reference device

Cited as predicate

7

7 submissions cite K180353 as a predicate