K192113 is an FDA 510(k) clearance for the DRSplus. This device is classified as a Ophthalmoscope, Laser, Scanning (Class II - Special Controls, product code MYC).
Submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on November 15, 2019, 102 days after receiving the submission on August 5, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K192113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MYC - Ophthalmoscope, Laser, Scanning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |