Submission Details
| 510(k) Number | K112192 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2011 |
| Decision Date | October 25, 2011 |
| Days to Decision | 88 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
Oct 2011
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K112192 is an FDA 510(k) clearance for the NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on October 25, 2011, 88 days after receiving the submission on July 29, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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