510(k) K110951 ยท HQB Photocoagulator And Accessories
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
| Applicant | Alcon Research, Ltd., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 17, 2011 |
| Received | Apr 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2025 | Alcon Research LLC CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:
25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093;
25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095;
27+ TOTALPLUS CP PAK Open, Classified |
HQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.