Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
5 total · filtered by GEX
| 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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Diode Laser Therapy Machine
Dermatological Diode Laser Systems
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Fraxis
PicoSecond Nd: YAG Laser System
Picosecond Laser System (Model PS10-A and PS10-B)
Picosecond Nd:YAG Laser System; PICO LEGEND
Diode Laser Hair Removal System
Zhengzhou PZ Laser Slim Technology Co., Ltd. references 12 predicate/reference devices
Diode laser hair removal machine (QDTM-02)
Diode Laser Therapy Systems
Dermatological Diode Laser Systems
Diode Laser Therapy Systems
Laser Therapy Device
Diode Laser Hair Removal Machine
Diode Laser 808nm
7 submissions cite Zhengzhou PZ Laser Slim Technology Co., Ltd. as a predicate