K210051 is an FDA 510(k) clearance for the OTE MPS 045 Multi-purpose Lens Care Solution. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Ote North America, LLC (Inwood, US). The FDA issued a Cleared decision on May 26, 2021, 138 days after receiving the submission on January 8, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K210051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2021 |
| Decision Date | May 26, 2021 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN - Accessories, Soft Lens Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |