510(k) K212630 ยท HQF Laser, Ophthalmic
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
| Applicant | Ellex Medical Pty, Ltd., Adelaide, AU |
| Decision | Substantially Equivalent, Dec 16, 2021 |
| Received | Aug 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212630
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.