Class Class II
Retitrack (K222484)
Description
Retitrack by C. Light Technologies, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222484
Clearance Date2023-05-09
Clearance TypeTraditional
Product CodeHLL
Regulation Number886.1510
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222484
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Retitrack (K222484) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181771 | RightEye Vision System | Righteye, LLC | 2018 |
| K152890 | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Ober Consulting Sp. Z.O.O. | 2016 |
| K150320 | COMPASS | Centervue S.P.A. | 2015 |
Trace the full predicate network for K222484
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.