Submission Details
| 510(k) Number | K161819 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2016 |
| Decision Date | November 25, 2016 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
NNR06 Multi-Purpose Solution
Nov 2016
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K161819 is an FDA 510(k) clearance for the NNR06 Multi-Purpose 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 November 25, 2016, 147 days after receiving the submission on July 1, 2016. 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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