510(k) K221768

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses by Paragon Vision Sciences, Inc. — Product Code HQD

K221768 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences, Inc. for the device "Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on May 5, 2023. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences, Inc. has at least 10 other 510(k) clearances on record.