K050948 is an FDA 510(k) clearance for the PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on May 18, 2005, 33 days after receiving the submission on April 15, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K050948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2005 |
| Decision Date | May 18, 2005 |
| Days to Decision | 33 days |
| Submission Type | Abbreviated |
| 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 |