510(k) K021566 ยท HQC Unit, Phacofragmentation
INFINITI
| Applicant | Alcon Laboratories, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, Jul 2, 2002 |
| Received | May 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2023 | Alcon Research, LTD. Infinity FMS Pak Open, Classified |
HQC | None listed |
| Sep 15, 2016 | Alcon Research, Ltd. LAUREATE World Phaco System Terminated |
HQC | None listed |
| May 3, 2016 | Alcon Research, Ltd. INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723.
An ophthalmic microsurgical system indicated for phacoemulsification and removal of c Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.