FDA 510(k) Premarket Notification K992500: CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS

Submission Details & Decision

Normalized public record details for 510(k) notification K992500.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K992500

Applicant / Sponsor

Cantor & Silver , Ltd.

Device Name

CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS

Product Code

LPL

Decision Date

1999-08-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

1999-07-26

Related Establishments / Registrations

BENZ RESEARCH AND DEVELOPMENT LLC Registration: 1052446 View Registration
Alcon Research, LLC Registration: 1053053 View Registration
JOHNSON & JOHNSON VISION CARE, INC. Registration: 1057985 View Registration
X-CEL SPECIALTY CONTACTS Registration: 1065845 View Registration
Orion Vision Registration: 1066578 View Registration
HOOD CONTAINER CORPORATION Registration: 1067084 View Registration
Bausch & Lomb Incorporated Registration: 1119279 View Registration
Bausch & Lomb Incorporated Registration: 1123818 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
COOPERVISION, INC. Registration: 1314956 View Registration
Bausch & Lomb Incorporated Registration: 1315522 View Registration
Alcon Research, LLC Registration: 1610287 View Registration
Metro Optics of Austin, Inc. Registration: 1627258 View Registration
ART OPTICAL CONTACT LENS, INC. Registration: 1835957 View Registration
OPTICAL CONNECTION TECHNOLOGY INC. Registration: 2024119 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
COOPERVISION Manufacturing Puerto Rico, LLC Registration: 2640128 View Registration
ABB Optical Group LLC. Registration: 2916547 View Registration
UNITED CONTACT LENS INC Registration: 2918644 View Registration
KONTUR KONTACT LENS CO., INC. Registration: 2919245 View Registration
TAPASZTO OPTIC LTD. Registration: 3002296055 View Registration
WINSTON OPTICAL D/B/A WINSTON TECHNOLOGY SYSTEMS, CORP. Registration: 3002732585 View Registration
Menicon Co., Ltd., Seki Plant Registration: 3002807570 View Registration
Menicon Co., Ltd., R&D Center Registration: 3003062331 View Registration
Alcon Canada Registration: 3003228982 View Registration
Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre Registration: 3003365815 View Registration
MENICON AMERICA, INC. Registration: 3003515967 View Registration
CIBA VISION ASIAN MANUFACTURING AND LOGISTICS Pte. Ltd. Registration: 3003657720 View Registration
COOPERVISION MANUFACTURING, LTD. Registration: 3003981983 View Registration
YUNG SHENG OPTICAL CO., LTD. Registration: 3004021238 View Registration
INTEROJO INC. Registration: 3004146030 View Registration
Visco Vision Inc. Registration: 3004529384 View Registration
PRIME DISTRIBUTORS LLC Registration: 3004585750 View Registration
SPECIALEYES LLC Registration: 3004927493 View Registration
ADVANCED VISION TECHNOLOGIES Registration: 3005147469 View Registration
Acucon Registration: 3005184723 View Registration
INTEGRATED SUPPLY CHAIN SDN. BHD. Registration: 3005395964 View Registration
COOPERVISION INC. Registration: 3005724763 View Registration
SOLOTICA INDUSTRIA E COMERCIO LTDA Registration: 3005994941 View Registration
ADVANCED CONCEPT INNOVATIONS LLC Registration: 3006015326 View Registration
CIBA VISION JOHOR SDN.BHD., Registration: 3006186389 View Registration
ALLIANCE OPTICAL GROUP ULC Registration: 3006297986 View Registration
SAFILENS S.R.L. Registration: 3006405660 View Registration
CooperVision Manufacturing Ltd Registration: 3006514242 View Registration
VISION SCIENCE CO., LTD. Registration: 3006946962 View Registration
DISTRIBUIDORA INTERNACIONAL ARMAZONES MEXICO SA DE CV Registration: 3007064560 View Registration
VASSEN CO., LTD. Registration: 3008034930 View Registration
OPTICAL SUPPLIES COMPANY SARL Registration: 3008325767 View Registration
FINE VISION OPTICAL COMPANY Registration: 3008504746 View Registration
GEO MEDICAL CO., LTD Registration: 3008585940 View Registration
CooperVision Manufacturing, LTD. Registration: 3008586477 View Registration
INFAR INTERNATIONAL PTE LTD Registration: 3009076545 View Registration
Menicon Singapore Pte. Ltd. Registration: 3009104180 View Registration
CooperVision CL KFT Registration: 3009108089 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
VISCO TECHNOLOGY SDN. BHD Registration: 3009633067 View Registration
NEO VISION CO., LTD. Registration: 3009674807 View Registration
VISIONEERING TECHNOLOGIES, INC Registration: 3010364480 View Registration
PEGAVISION CORPORATION Registration: 3010392968 View Registration
DreamCon Co. Ltd. Registration: 3010460316 View Registration
KELABIT S.R.O. Registration: 3010640396 View Registration
ANGEL EYE CENTRE LTD. Registration: 3010890435 View Registration
1800 CONTACTS, INC Registration: 3011080538 View Registration
SHOTLEY LIMITED Registration: 3011521050 View Registration
QUALIMED SRL Registration: 3011553378 View Registration
LENS GLOBAL Limited Registration: 3011649033 View Registration
CooperVision, Inc. Registration: 3011771819 View Registration
Menicon Singapore Pte. Ltd. (Site 2) Registration: 3011861185 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
CooperVision Manufacturing Costa Rica SRL Registration: 3012123291 View Registration
Imperial Optical, Inc Registration: 3012138439 View Registration
General Trading & Services S.R.L. Registration: 3012167421 View Registration
ACUITY POLYMERS INC. Registration: 3012228452 View Registration
BOLD VISION GROUP LIMITED Registration: 3012546757 View Registration
EYEYON MEDICAL Registration: 3012590738 View Registration
SHINYEYES INC. Registration: 3012719596 View Registration
Maxvue Vision Sdn. Bhd. Registration: 3012760082 View Registration
TANGIBLE SCIENCE Inc Registration: 3012862899 View Registration
JOOWON INNOVATION CO., LTD. Registration: 3012918760 View Registration
GO PRO NOW LTD Registration: 3013124682 View Registration
UNICON OPTICAL CO., LTD. Registration: 3013170070 View Registration
SEINOH OPTICAL CO., LTD Registration: 3013505369 View Registration
SUPERVISION OPTIMAX SDN BHD Registration: 3013576528 View Registration
CAMDEN PASSAGE Registration: 3013785060 View Registration
ARCADANT B.V. Registration: 3014054090 View Registration
PARCEX ESTRATEGIA Y NEGOCIO SA DE CV Registration: 3014289638 View Registration
Menicon Co., Ltd., Kakamigahara Plant Registration: 3014768085 View Registration
VIZIONFOCUS INC. Registration: 3015146121 View Registration
FOCUS PROVEEDORA SA DE CV Registration: 3015282628 View Registration
LM GLOBAL ENTERPRISES LTD. Registration: 3015332516 View Registration
E.O.S CO., LTD. Registration: 3015369246 View Registration
OPTIMAX EYEWEAR INC Registration: 3015393207 View Registration
HARLEIGH (MALAYSIA) SDN. BHD. Registration: 3015430860 View Registration
ELEVATE SOLUTIONS GROUP, LLC Registration: 3015533540 View Registration
WISCONSIN VISION ASSOCIATES INC. Registration: 3015700153 View Registration
ZONEDIN VISION LLC Registration: 3016009612 View Registration
KITS EYECARE LTD Registration: 3017069344 View Registration
Ciba Vision Asian Manufacturing and Logistics PTE, LTD Registration: 3017889743 View Registration
PEGAVISION CORPORATION-DAXI Registration: 3018616050 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
SKR ALLIANCE Registration: 3022375855 View Registration
DK MEDIVISION CO., LTD. Registration: 3024762292 View Registration
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD. Registration: 3025414414 View Registration
Innova Vision Inc. Registration: 3026035637 View Registration
LENS PRO LTD Registration: 3030261726 View Registration
DIMPLE OPTICS PTY LTD Registration: 3030262618 View Registration
ENLACES CORPORATIVOS 55 DEL NORTE S.A. DE C.V. Registration: 3030421258 View Registration
3D GLOBAL BIOTECH INC. Registration: 3031092085 View Registration
MENICON CO. LTD. Global Logistics Center Registration: 3033524682 View Registration
1462287 BC UNLIMITED LIABILITY COMPANY Registration: 3035373204 View Registration
E-VISION ADVISORS LTD Registration: 3035385765 View Registration
ZUMRUT LENS SAGLIK HIZM. VE OPTIK UR. DIS. TIC. LTD. STI. Registration: 3036689755 View Registration
SHENZHEN LENSGOO VISION CO., LTD. Registration: 3039456814 View Registration
BLOOM MAX LIMITED Registration: 3039590526 View Registration
HUNAN HAIPUMING TECHNOLOGY CO.,LTD. Registration: 3041165456 View Registration
METI OPTICAL INC Registration: 3043022738 View Registration
OPTIKAL (SOUTHGATE) LTD Registration: 3044710860 View Registration
UPS Supply Chain Solutions, Inc. Registration: 3044853379 View Registration
OBJECTT OPTIK COMPANY LIMITED Registration: 8040277 View Registration
Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland Registration: 9610731 View Registration
CANTOR BARNARD LTD Registration: 9610790 View Registration
CIBA VISION GMBH Registration: 9610813 View Registration
CLEARLAB SG PTE, LTD. Registration: 9614154 View Registration
COOPERVISION MANUFACTURING, LTD. Registration: 9614392 View Registration
MENICON CO. LTD. Registration: 9614761 View Registration
ST. SHINE OPTICAL CO., LTD. Registration: 9617499 View Registration
JOHNSON & JOHNSON VISION CARE IRELAND UNLIMITED COMPANY Registration: 9617710 View Registration
GELFLEX LABORATORIES Registration: 9680540 View Registration
PT. CIBA VISION BATAM Registration: 9681121 View Registration
MI GWANG CONTACT LENS CO., LTD. Registration: 9710495 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.