Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768)
Description
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses by Paragon Vision Sciences, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221768
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. Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 |
Trace the full predicate network for K221768
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.