K191872 is an FDA 510(k) clearance for the Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on March 2, 2020, 234 days after receiving the submission on July 12, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K191872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2019 |
| Decision Date | March 02, 2020 |
| Days to Decision | 234 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 |