510(k) K161100

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses by Contamac, Ltd. — Product Code HQD

K161100 is an FDA 510(k) premarket notification submitted by Contamac, Ltd. for the device "Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses". The FDA issued a decision of Substantially Equivalent on August 10, 2016. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Contamac, Ltd. has at least 10 other 510(k) clearances on record.