K173136 is an FDA 510(k) clearance for the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses. This device is classified as a Products, Contact Lens Care, Rigid Gas Permeable (Class II - Special Controls, product code MRC).
Submitted by Menicon Co, Ltd. (Nagoya, JP). The FDA issued a Cleared decision on November 16, 2017, 48 days after receiving the submission on September 29, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K173136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | November 16, 2017 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRC - Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5918 |