510(k) K243121 ยท GEX Powered Laser Surgical Instrument
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-
| Applicant | Jiangxi Medex Technology Co., Ltd., Jiangxi, CN |
| Decision | Substantially Equivalent, Dec 22, 2024 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243121
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.