510(k) K101325 ยท HQC Unit, Phacofragmentation
STELLARIS PC VISION ENHANCEMENT SYSTEM
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 17, 2010 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2012 | Bausch & Lomb Inc Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectom Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.