510(k) K070669 ยท KYB Lens, Guide, Intraocular
IOL INJECTOR SET
| Applicant | Medicel AG, Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Nov 1, 2007 |
| Received | Mar 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070669
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2013 | Medicel Ag Product Name: nanoPOINT Injector System, item number 37-0000-08.
Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. Terminated |
HQL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.