510(k) K955900

NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR by Novavision, Inc. — Product Code HQD

K955900 is an FDA 510(k) premarket notification submitted by Novavision, Inc. for the device "NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Novavision, Inc. has at least 2 other 510(k) clearances on record.