510(k) K223132 · HQF Laser, Ophthalmic
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
| Applicant | Iridex Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Nov 9, 2022 |
| Received | Oct 3, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223132
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.