510(k) K240386 ยท GEX Powered Laser Surgical Instrument
Picosecond Nd:YAG Laser Systems (BL-C10)
| Applicant | Shanghai Bele Medical Technology Co.,Ltd, Shanghai, CN |
| Decision | Substantially Equivalent, May 16, 2024 |
| Received | Feb 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240386
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.