Submission Details
| 510(k) Number | K050717 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2005 |
| Decision Date | May 13, 2005 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
May 2005
Decision
53d
Days
Class 2
Risk
About This 510(k) Submission
K050717 is an FDA 510(k) clearance for the PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on May 13, 2005, 53 days after receiving the submission on March 21, 2005. 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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