510(k) K052983

FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES by Paragon Vision Sciences — Product Code HQD

K052983 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on February 10, 2006. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.