Retitrack
FDA 510(k) clearance K222484 · decided 2023-05-09
Clearance details
- K-number
- K222484
- Device name
- Retitrack
- Applicant
- C. Light Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-17
- Decision date
- 2023-05-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- HLL
- Device class
- 2
- Regulation number
- 886.1510
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Medford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SACCADOMETER PLUS, SACCADOMETER ADVANCED (K152890) | Ober Consulting Sp. Z.O.O. | 2016-08-11 |
| VARILUX VISIONPRINT SYSTEM (VPS) (K033949) | Essilor Intl. | 2004-07-02 |
| ORTHOTONE (K872111) | Orthotone Corp. | 1988-11-16 |
Recalls involving this device
No recalls on record reference this clearance.