Submission Details
| 510(k) Number | K151918 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 2015 |
| Decision Date | February 11, 2016 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
Feb 2016
Decision
213d
Days
Class 2
Risk
About This 510(k) Submission
K151918 is an FDA 510(k) clearance for the Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on February 11, 2016, 213 days after receiving the submission on July 13, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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