K882814 is an FDA 510(k) clearance for the NEOLENS PRESCRIPTION SPECTACLE LENS. This device is classified as a Lens, Spectacle, Non-custom (prescription) (Class I - General Controls, product code HQG).
Submitted by Neolens, Inc. (Miami, US). The FDA issued a Cleared decision on July 29, 1988, 21 days after receiving the submission on July 8, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5844.
| 510(k) Number | K882814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1988 |
| Decision Date | July 29, 1988 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQG — Lens, Spectacle, Non-custom (prescription) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5844 |