510(k) K133486 ยท HQC Unit, Phacofragmentation
STELLARIS PC VISION ENHANCEMENT SYSTEM
| Applicant | Bausch & Lomb, St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 12, 2014 |
| Received | Nov 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2014 | Bausch & Lomb Inc Bausch & Lomb Stellaris PC w/ Laser, BL14304
The responsible firm name is Bausch & Lomb Incorporated Rochester, NY Terminated |
HQF | None listed |
| Dec 23, 2014 | Bausch & Lomb Inc Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit)
Stellaris PC Vision Enhancement System with integrated laser module. System is used for Terminated |
HQF | None listed |
| Dec 23, 2014 | Bausch & Lomb Inc Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit)
Stellaris PC Vision Enhancement System with integrated laser module. System is used f Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.