Submission Details
| 510(k) Number | K112909 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2011 |
| Decision Date | April 30, 2012 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
Apr 2012
Decision
210d
Days
Class 2
Risk
About This 510(k) Submission
K112909 is an FDA 510(k) clearance for the OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on April 30, 2012, 210 days after receiving the submission on October 3, 2011. 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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