Submission Details
| 510(k) Number | K050250 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 2005 |
| Decision Date | August 10, 2005 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
Cleared
Traditional
AQUIFY MULTIPURPOSE SOLUTION
Aug 2005
Decision
188d
Days
Class 2
Risk
About This 510(k) Submission
K050250 is an FDA 510(k) clearance for the AQUIFY MULTIPURPOSE SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on August 10, 2005, 188 days after receiving the submission on February 3, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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