Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
6 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | GEX | Class 2 | 2024-12-20 |
| K231896 | Diode Laser Therapy System | GEX | Class 2 | 2024-02-20 |
| K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | GEX | Class 2 | 2022-08-23 |
| K161926 | ND YAG Q-switch Laser Therapy Machine | GEX | Class 2 | 2017-02-22 |
| K161692 | Diode Laser Therapy Machine | GEX | Class 2 | 2016-11-16 |
| K161925 | CO2 Laser Therapy Machine | GEX | Class 2 | 2016-10-05 |
CO2 Laser System
Diode Laser Therapy Systems
The Alma Soprano Titanium
PicoSecond Nd: YAG Laser System
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Beijing Adss Development Co., Ltd. references 9 predicate/reference devices
CO2 Laser Therapy System (K106)
Picosecond laser device (BMPS4)
Picosecond Laser Device (PF131-BI)
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
CO2 Laser System (CO2 Laser SST-L23)
Medical Picosecond ND: YAG Laser System (PZ-6)
CO2 Laser Therapy Systems (SHE-LSP003-1)
CO2 Laser Therapy Systems (SHE-LSP003-1)
Q-Switched Nd:Yag laser
MEDIYAG
ProFlex CO2 Laser Fiber
CO2 Laser System
ND:YAG Laser
ND:YAG Laser
CO2 Laser Therapy System
Diode Laser Hair Removal System
Diode Laser Treatment System
New Era
18 submissions cite Beijing Adss Development Co., Ltd. as a predicate