FDA.reportPublic FDA data

GELFLEX LABORATORIES

Matched from indexed company URL: Gelflex Laboratories

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96805401000426389GELFLEX LABORATORIES1N2026-01-0152 MULGUL ROAD MALAGA PERTH Western Australia AU 6090

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
821731372429071K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact LensLPL2018-09-06
821731391649898K033599ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSHQD2004-09-16
821731172946633K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%LPL2003-04-01
821732027860889K024003GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONTLPL2003-02-05
821731106429007K013762RIGID GAS PERMEABLE CONTACT LENSHQD2002-04-03
821731260491386

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPL62018-09-06
HQD22004-09-16

PMN#