K082850 is an FDA 510(k) clearance for the EYE SPHERES. This device is classified as a Implant, Eye Sphere (Class II — Special Controls, product code HPZ).
Submitted by Product and Educational Services, LLC (Doylestown, US). The FDA issued a Cleared decision on February 27, 2009, 151 days after receiving the submission on September 29, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K082850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | February 27, 2009 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPZ — Implant, Eye Sphere |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.3320 |