K052560 is an FDA 510(k) clearance for the BIOFINITY (COMFILCON A) SOFT CONTACT LENS. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 6, 2005, 81 days after receiving the submission on September 16, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K052560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2005 |
| Decision Date | December 06, 2005 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |