Class Class II
Tixel i (TXLI0001) (K240512)
Description
Tixel i (TXLI0001) by Novoxel , Ltd., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240512
Clearance Date2024-11-04
Clearance TypeTraditional
Product CodeORZ
Regulation Number886.5200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240512
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. Tixel i (TXLI0001) (K240512) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 |
| K223033 | Tixel® 2 System | Novoxel , Ltd. | 2023 |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2019 |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017 |
Trace the full predicate network for K240512
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.