510(k) K033599

ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS by The Lagado Corp. — Product Code HQD

K033599 is an FDA 510(k) premarket notification submitted by The Lagado Corp. for the device "ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. The Lagado Corp. has at least 4 other 510(k) clearances on record.