Submission Details
| 510(k) Number | K070637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2007 |
| Decision Date | May 01, 2007 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
K070637 is an FDA 510(k) clearance for the FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES. This device is classified as a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD).
Submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on May 1, 2007, 55 days after receiving the submission on March 7, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K070637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2007 |
| Decision Date | May 01, 2007 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |