510(k) K213225 ยท GEX Powered Laser Surgical Instrument
Diode Laser System GP900A8, Diode Laser System GP900Q8
| Applicant | Shenzhen Gsd Tech Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213225
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.