Class Class II
MINI VP1 (PL67_F); MINI VP1 (PL61_F) (K250495)
Description
MINI VP1 (PL67_F); MINI VP1 (PL61_F) by Avizor S.A., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250495
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeLRX
Regulation Number886.5928
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250495
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. MINI VP1 (PL67_F); MINI VP1 (PL61_F) (K250495) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model ... | Shanghai Care US Medical Product Co... | 2024 |
Trace the full predicate network for K250495
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.