510(k) K081178

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES by Contamac, Ltd. — Product Code HQD

K081178 is an FDA 510(k) premarket notification submitted by Contamac, Ltd. for the device "OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on October 9, 2008. 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.