Class Class II
TearCare MGX System (K242786)
Description
TearCare MGX System by Sight Sciences, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242786
Clearance Date2025-04-15
Clearance TypeTraditional
Product CodeORZ
Regulation Number886.5200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242786
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. TearCare MGX System (K242786) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026 |
Trace the full predicate network for K242786
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.