Submission Details
| 510(k) Number | K031957 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 25, 2003 |
| Decision Date | August 14, 2003 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
Aug 2003
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K031957 is an FDA 510(k) clearance for the MODIFICATION TO KARATS MULTI-PURPOSE 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 14, 2003, 50 days after receiving the submission on June 25, 2003. 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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