FDA 510(k) Applications Submitted by Gelflex Laboratories

FDA 510(k) Number Submission Date Device Name Applicant
K181558 06/13/2018 Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens Gelflex Laboratories
K030027 01/03/2003 GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% GELFLEX LABORATORIES
K962710 06/10/1996 GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS GELFLEX LABORATORIES
K962711 06/10/1996 GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS GELFLEX LABORATORIES


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