Class Class I
TearRepair Liquid Skin Protectant (K241916)
Description
TearRepair Liquid Skin Protectant by Optmed, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK241916
Clearance Date2024-09-27
Clearance TypeTraditional
Product CodeKMF
Regulation Number880.5090
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241916
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. TearRepair Liquid Skin Protectant (K241916) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K133443 | MARATHON NO STING LIQUID SKIN PROTECTANT | Advanced Medical Solutions (Plymout... | 2014 |
Trace the full predicate network for K241916
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.