Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
11 total · filtered by GEX
Showing 1–11
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K243780 | HELIOS 785 Pico (1754V2) | GEX | Class 2 | 2025-02-07 |
| K230373 | HELIOS 785 Pico | GEX | Class 2 | 2023-05-22 |
| K223588 | PALLAS Premium | GEX | Class 2 | 2023-01-26 |
| K212663 | HELIOS IV 785 | GEX | Class 2 | 2022-06-09 |
| K212573 | PicoLO Premium | GEX | Class 2 | 2021-12-08 |
| K203491 | PicoLO Nd: YAG Picosecond Laser System | GEX | Class 2 | 2021-04-07 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | GEX | Class 2 | 2020-01-03 |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | GEX | Class 2 | 2019-01-04 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | GEX | Class 2 | 2018-12-27 |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | GEX | Class 2 | 2017-11-03 |
| K152856 | Helios III | GEX | Class 2 | 2016-06-02 |
Companies whose devices this company cited as predicates
6 manufacturers
Companies that cited this company's devices as predicates
4 manufacturers