K222484 is an FDA 510(k) clearance for the Retitrack. This device is classified as a Monitor, Eye Movement (Class II - Special Controls, product code HLL).
Submitted by C. Light Technologies, Inc. (Medford, US). The FDA issued a Cleared decision on May 9, 2023, 265 days after receiving the submission on August 17, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1510.
| 510(k) Number | K222484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2022 |
| Decision Date | May 09, 2023 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLL - Monitor, Eye Movement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1510 |