510(k) K121555 ยท HQC Unit, Phacofragmentation
CENTURION VISION SYSTEM
| Applicant | Alcon Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 21, 2012 |
| Received | May 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2023 | Alcon Research, LTD. Centurion FMS Pak Open, Classified |
HQC | None listed |
| Aug 16, 2023 | Alcon Research, LTD. Phaco Standalone Tips Open, Classified |
HQC | None listed |
| Jun 28, 2016 | Alcon Research, Ltd. CENTURION Vision System Terminated |
HQC | None listed |
| Jun 9, 2016 | Alcon Research, Ltd. CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.