Submission Details
| 510(k) Number | K111877 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2011 |
| Decision Date | January 24, 2012 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
Jan 2012
Decision
207d
Days
Class 2
Risk
About This 510(k) Submission
K111877 is an FDA 510(k) clearance for the EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION, 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 January 24, 2012, 207 days after receiving the submission on July 1, 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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