510(k) K052507

TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR by The Lagado Corp. — Product Code HQD

K052507 is an FDA 510(k) premarket notification submitted by The Lagado Corp. for the device "TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR". The FDA issued a decision of Substantially Equivalent on November 2, 2005. 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.