510(k) K142398 ยท HQF Laser, Ophthalmic
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
| Applicant | Ellex Medical Pty, Ltd., Adelaide, AU |
| Decision | Substantially Equivalent, Jul 14, 2015 |
| Received | Aug 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2023 | Ellex Medical Pty Ltd. Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532
Spare, Optics Bench V2, L2G/LP6G Open, Classified |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.