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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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