K083757 is an FDA 510(k) clearance for the BPZ02 MULTIPURPOSE SOLUTION. This device is classified as a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II - Special Controls, product code LYL).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 18, 2009, 336 days after receiving the submission on December 17, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K083757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2008 |
| Decision Date | November 18, 2009 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYL - Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |