Submission Details
| 510(k) Number | K083757 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
BPZ02 MULTIPURPOSE SOLUTION
Nov 2009
Decision
336d
Days
Class 2
Risk
About This 510(k) Submission
K083757 is an FDA 510(k) clearance for the BPZ02 MULTIPURPOSE SOLUTION, 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 review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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