510(k) K101285 ยท HQC Unit, Phacofragmentation
CONSTELLATION VISION SYSTEM
| Applicant | Alcon Manufacturing, Ltd., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 12, 2010 |
| Received | May 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2023 | Alcon Research, LLC Constellation Vision System, REF: 8065751150 Open, Classified |
HQC | None listed |
| Jul 25, 2018 | Alcon Research LLC Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. Terminated |
HQC | None listed |
| Jan 12, 2018 | Alcon Research, LTD. Alcon 25+ TOT ALPLUS Vitrectomv Pak
Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. Terminated |
HQC | None listed |
| Jan 12, 2018 | Alcon Research, LTD. Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.)
Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.