Submission Details
| 510(k) Number | K132216 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2013 |
| Decision Date | September 09, 2013 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
Sep 2013
Decision
54d
Days
Class 2
Risk
About This 510(k) Submission
K132216 is an FDA 510(k) clearance for the BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on September 9, 2013, 54 days after receiving the submission on July 17, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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