Submission Details
| 510(k) Number | K123202 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 12, 2012 |
| Decision Date | May 30, 2013 |
| Days to Decision | 230 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
May 2013
Decision
230d
Days
Class 2
Risk
About This 510(k) Submission
K123202 is an FDA 510(k) clearance for the PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 30, 2013, 230 days after receiving the submission on October 12, 2012. 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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