510(k) K052560 ยท LPL Lenses, Soft Contact, Daily Wear
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
| Applicant | CooperVision, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 6, 2005 |
| Received | Sep 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052560
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2017 | CooperVision Inc. Biofinity XR Toric contact lenses 8.7/14.5 - 6PK
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmati Terminated |
LPM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.