FDA.reportPublic FDA data

X-CEL SPECIALTY CONTACTS

Matched from indexed company URL: X-Cel Specialty Contacts

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10658453003040707X-CEL SPECIALTY CONTACTS1N2026-01-012775 Premiere Pkwy Ste 600 DULUTH GA US 30097

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58851575151808P830012
58851218127079K992010W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)LPL1999-06-29
58851034658354K963837HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANLPL1996-12-20
58851085699456K962121HORIZON/WESTHIN 55-GLPL1996-08-26
58851755111193K962000FLEXLENS(METHAFILCON A)LPL1996-10-01
58851865393807K961943FLEXLENSLPL1996-10-01
58851726758025K954524W-55 (METHAFILON A) CONTACT LENSLPL1996-03-28
58851032705410K950818HORIZON 55 BI-CON TORICLPL1995-03-21
58851304519184K950294FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENSLPL1996-04-11
58851375091830K945365HORIZON 55 BI-CONLPL1994-12-28
58851896125526K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)LPL2024-08-14
58851300861497K100443DEFINITIVE, FLEXLENS - SILICONE HYDROGELLPL2010-10-28
58851920119445K080686WESTCON HORIZON 49% (HIOXIFILCON B)LPL2008-04-22
58851783033469K070308FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEARLPL2007-03-12
58851842608420K043540HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSESLPL2005-02-01
58851274891922K031774HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSESLPL2004-02-20
58851902691066K030593FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTACLPL2003-05-30
58851534536750K023530HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)LPL2002-11-26
58851002118111
58851009230767
58851014661671
58851063832128
58851147125625
58851158034959
58851168082988
58851186895413
58851230220667
58851244700797
58851261441283
58851332367209
58851370298560
58851413719375
58851437165080
58851447784204
58851475755751
58851486013517
58851504413519
58851562737932
58851592647012
58851645091164
58851647200297
58851657990097
58851694139557
58851861402983
58851867469579
58851892858694
58851939376589
58852007737173
58852024375821
58852060933724

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPL172024-08-14

PMN#

GUDID#