K011945 is an FDA 510(k) clearance for the RIGID GAS PERMEABLE CONTACT LENS SOLUTION. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on September 12, 2001, 83 days after receiving the submission on June 21, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K011945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2001 |
| Decision Date | September 12, 2001 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |