510(k) K163254

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens by Acuity Polymers, Inc. — Product Code HQD

K163254 is an FDA 510(k) premarket notification submitted by Acuity Polymers, Inc. for the device "Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens". The FDA issued a decision of Substantially Equivalent on January 18, 2017. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Acuity Polymers, Inc. has at least 10 other 510(k) clearances on record.