Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
Cited as predicate
FDA product code distribution
2 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | GEX | Class 2 | 2024-12-26 |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | GEX | Class 2 | 2024-12-22 |
No later 510(k)s cite this device yet
Other submissions will appear here when they list Jiangxi Medex Technology Co., Ltd. as a predicate