K003299 is an FDA 510(k) clearance for the OPD-SCAN, MODELS ARK-10000 AND ARK-9000. This device is classified as a Keratoscope, Ac-powered (Class I - General Controls, product code HLQ).
Submitted by Nidek Co., Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 9, 2001, 140 days after receiving the submission on October 20, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1350.
| 510(k) Number | K003299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | October 20, 2000 |
| Decision Date | March 09, 2001 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLQ — Keratoscope, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1350 |