Submission Details
| 510(k) Number | K080755 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 17, 2008 |
| Decision Date | June 10, 2008 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Jun 2008
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K080755 is an FDA 510(k) clearance for the SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY 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 June 10, 2008, 85 days after receiving the submission on March 17, 2008. 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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