Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
2 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | GEX | Class 2 | 2025-09-25 |
| K211977 | Medical Diode Laser Systems | GEX | Class 2 | 2021-10-26 |
Medical Diode Laser Systems (VeinCure)
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
Medical Diode Laser, Model S1Pro
3 submissions cite Wuhan Dimed Laser Technology Co., Ltd. as a predicate