Product areas
FDA product code distribution
FDA product code distribution
5 total
Showing 1–5
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | GEX | Class 2 | 2025-10-03 |
| K250065 | DENSITY; DENZA; DENSITY Noir | GEI | Class 2 | 2025-07-08 |
| K223685 | SmoothCool HR System | GEX | Class 2 | 2023-01-04 |
| K213484 | SmoothCool HR System | GEX | Class 2 | 2022-04-20 |
| K162169 | EdgeOne CO2 Laser | GEX | Class 2 | 2016-10-27 |
Companies whose devices this company cited as predicates
3 manufacturers
Companies that cited this company's devices as predicates