Submission Details
| 510(k) Number | K031753 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2003 |
| Decision Date | October 28, 2004 |
| Days to Decision | 511 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
KARATS MULTIPURPOSE SOLUTION
Oct 2004
Decision
511d
Days
Class 2
Risk
About This 510(k) Submission
K031753 is an FDA 510(k) clearance for the KARATS 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 October 28, 2004, 511 days after receiving the submission on June 5, 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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