510(k) K213164 ยท LPL Lenses, Soft Contact, Daily Wear
Avaira Vitality
| Applicant | CooperVision, Inc., San Ramon CA, US |
| Decision | Substantially Equivalent, Oct 26, 2021 |
| Received | Sep 28, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | CooperVision, Inc. Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens;
Model/Catalog Number: Softmed Breathables Advanced Toric
Product Description: 55% water content, toric, Open, Classified |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.