510(k) K233876 ยท HQC Unit, Phacofragmentation
UNITY VCS (8065000296); UNITY CS (8065000297)
| Applicant | Alcon Laboratories, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, Jun 21, 2024 |
| Received | Dec 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UN Open, Classified |
MLZ | None listed |
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PA Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.