510(k) K100253 ยท HQF Laser, Ophthalmic
VISUMAX LASER KERATOME
| Applicant | Carl Zeiss Meditec, AG, Dublin CA, US |
| Decision | Substantially Equivalent, Jul 8, 2010 |
| Received | Jan 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2014 | Carl Zeiss Meditec AG Treatment packs used on the VisuMax Laser Keratome.
Size M
Manufactured by Carl Zeiss Meditec AG,
Jena, Germany.
The VisuMax Laser Keratome is indicated for the following: In the creation of a corne Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.