K812433 is an FDA 510(k) clearance for the LENSINE EXTRA STRENGTH CLEANER. This device is classified as a Lens, Contact (polymethylmethacrylate).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 21, 1981, 27 days after receiving the submission on August 25, 1981.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K812433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1981 |
| Decision Date | September 21, 1981 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPX — Lens, Contact (polymethylmethacrylate) |
| Device Class | — |