Submission Details
| 510(k) Number | K170483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 2017 |
| Decision Date | April 11, 2017 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Bausch + Lomb Sensitive Eyes Plus Saline Solution
Apr 2017
Decision
54d
Days
Class 2
Risk
About This 510(k) Submission
K170483 is an FDA 510(k) clearance for the Bausch + Lomb Sensitive Eyes Plus Saline 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 April 11, 2017, 54 days after receiving the submission on February 16, 2017. 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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