K093521 is an FDA 510(k) clearance for the GDXPRO. This device is classified as a Ophthalmoscope, Laser, Scanning (Class II - Special Controls, product code MYC).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on November 25, 2009, 12 days after receiving the submission on November 13, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K093521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2009 |
| Decision Date | November 25, 2009 |
| Days to Decision | 12 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 |