Class Class II
iCare ST500 (TA04) (K241447)
Description
iCare ST500 (TA04) by Icare Finland OY, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241447
Clearance Date2024-09-27
Clearance TypeTraditional
Product CodeHKY
Regulation Number886.1930
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241447
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. iCare ST500 (TA04) (K241447) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220852 | iCare IC200 | Icare Finland OY | 2022 |
Trace the full predicate network for K241447
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.