510(k) K153769 ยท HQF Laser, Ophthalmic
R:GEN Laser System
| Applicant | Lutronic Corporation, Goyang-Si, KR |
| Decision | Substantially Equivalent, Oct 5, 2016 |
| Received | Dec 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153769
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.