510(k) K030027

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% by Gelflex Laboratories — Product Code LPL

K030027 is an FDA 510(k) premarket notification submitted by Gelflex Laboratories for the device "GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%". The FDA issued a decision of Substantially Equivalent on Apr 1, 2003. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Gelflex Laboratories has 3 other 510(k) clearances on record.