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Gelflex Laboratories

FDA Regulatory Profile

Gelflex Laboratories has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 30, 2015 · NAI
Latest 510(k)
Sep 6, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 30, 2015Malaga, AustraliaDevicesNo Action Indicated (NAI)1000426389

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear…Sep 6, 2018
K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON…Apr 1, 2003
K962711GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENSSep 5, 1996
K962710GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENSSep 5, 1996

FDA data resources