Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.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
Product code
GEX
21 CFR 878.4810
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
1Diode Laser Hair Removal System
K180353 references 1 predicate/reference device
Cited as predicate
7Diode Laser 808nm
Diode Laser Hair Removal Machine
Laser Therapy Device
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Dermatological Diode Laser Systems
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Diode laser hair removal machine (QDTM-02)
7 submissions cite K180353 as a predicate
