510(k) K993357 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
IOLMASTER
| Applicant | Carl Zeiss, Inc., Thornwood NY, US |
| Decision | Substantially Equivalent, Mar 20, 2000 |
| Received | Oct 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 5.5: Software versions 7.5 and 7.7;
Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation Terminated |
HJO | None listed |
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 500: Software versions 7.5 and 7.7;
Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white Terminated |
HJO | None listed |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Ca Terminated |
HJO | None listed |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Terminated |
HJO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.