510(k) K974635

PARAGON LENS CARE by Paragon Vision Sciences — Product Code LRX

K974635 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "PARAGON LENS CARE". The FDA issued a decision of Substantially Equivalent on February 4, 1998. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.