Product areas
FDA product code distribution
FDA product code distribution
5 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | GEX | Class 2 | 2025-10-23 |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | GEX | Class 2 | 2025-07-25 |
| K250782 | Fractional CO2 Laser Machine | GEX | Class 2 | 2025-06-12 |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | GEX | Class 2 | 2025-05-14 |
| K180353 | Diode laser hair removal device | GEX | Class 2 | 2018-04-17 |
Joule System
Lavieen
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Zhengzhou PZ Laser Slim Technology Co., Ltd. references 12 predicate/reference devices
Diode laser hair removal machine (QDTM-02)
Diode Laser Therapy Systems
Beijing Lasertell Medical Co., Ltd.
Dermatological Diode Laser Systems
Beijing HuaCheng Taike Technology Co., Ltd.
Diode Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd.
Laser Therapy Device
Shenzhen Leaflife Technology Co., Ltd.
Diode Laser Hair Removal Machine
Beijing Lead Beauty S & T Co., Ltd.
Diode Laser 808nm
Beijing Superlaser Technology Co., Ltd.
7 submissions cite Zhengzhou PZ Laser Slim Technology Co., Ltd. as a predicate