510(k) K082473 ยท HQC Unit, Phacofragmentation
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 5, 2009 |
| Received | Aug 27, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K082473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Enhanc Terminated |
HQC | None listed |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111,
packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Enhance Terminated |
HQC | None listed |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Stellaris Vision Terminated |
HQC | None listed |
| Aug 30, 2011 | Bausch & Lomb Inc Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY
For use with the Bausch & Lomb Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.