K091339 is an FDA 510(k) clearance for the BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by CooperVision, Inc. (Norfolk, US). The FDA issued a Cleared decision on January 5, 2010, 244 days after receiving the submission on May 6, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K091339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2009 |
| Decision Date | January 05, 2010 |
| Days to Decision | 244 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 |