510(k) K142953 ยท HLI Ophthalmoscope, Ac-Powered
OCT-Camera
| Applicant | Optomedical Technologies GmbH, Luebeck, DE |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Oct 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Open, Classified |
HLI | None listed |
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 Open, Classified |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.