FDA 510(k) Applications for Medical Device:
Biomicroscope, Slit-Lamp, Ac-Powered

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K072861 ACHEVE TECHNOLOGY, INC. 17100 GILLETTE AVE., UNIT 113
IRVIN CA 92614
K974467 AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE
COTO DE CAZA CA 92679-4001
K082031 APPASAMY ASSOCIATES 20, SBI OFFICERS COLONY
ARUMBAKKAM, CHENNAI 600 106
K862515 BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST.
ROCHESTER NY 14692
K862516 BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST.
ROCHESTER NY 14692
K862520 BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST.
ROCHESTER NY 14692
K012873 BAUSCH & LOMB, INC. 9342 JERONIMO RD.
IRVINE CA 92618
K945445 BOBES S.A. CTRA. FUENTE DEL TORO, S/N
MADRID
K936209 CANON U.S.A., INC. ONE CANON PLAZA
LAKE SUCCESS NY 11042 1198
K101182 CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE
DUBLIN CA 94568
K122418 CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE
DUBLIN CA 94568
K170171 Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52
Jena 07445
K173771 Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52
Jena 07445
K162684 Carl Zeiss Meditec AG
Jena 07745
K133476 CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE
DUBLIN CA 94568
K161607 CARL ZEISS MEDITEC AG GOESCHWITZER STRASSE 54-52
JENA 07745
K141068 CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE
DUBLIN CA 94568
K143275 Carl Zeiss Meditec, Inc. 5160 Hacienda Drive
Dublin CA 94568-7562
K993357 CARL ZEISS, INC. ONE ZEISS DR.
THORNWOOD NY 10594
K925641 CARL ZEISS, INC. 305 COLLEGE RD. EAST
PRINCETON NJ 08540
K862004 CARL ZEISS, INC. ONE ZEISS DR.
THORNWOOD NY 10594
K874160 CARL ZEISS, INC. ONE ZEISS DR.
THORNWOOD NY 10594
K842859 CHIRON VISION CORP. 9342 JERONIMO RD.
IRVINE CA 92618 1903
K171877 Chongqing Kanghua Ruiming S&T Co., Ltd. No.5, Road1, Tongjiaxi Industrial Park, Beibei
Chongqing 400070
K182306 Chongqing Sunkingdom Medical Instrument Co Ltd 1012, Block A of China Resource Center
Chongqing 400050
K161764 CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD 5 DANLONG ROAD
NAN'AN DISTRICT 400060
K953965 CLEMENT CLARKE, INC. AIRMED HOUSE, EDINBURGH WAY
ENGLAND
K801659 COBURN OPTICAL IND., INC.
K862379 COMPUTED ANATOMY, INC. 310 EAST 14TH ST.
NEW YORK NY 10003
K970414 CON-S LTD. ONE GALLERIA BOULEVARD,
METAIRIE LA 70002
K992836 CSO 197 BELVOIR RD.
WILLIAMSVILLE NY 14221
K813313 DESIGN RESEARCH ASSOC., INC.
K962532 EXPERTECH ASSOC., INC. 100 MAIN ST.
CONCORD MA 01742
K982057 HAAG-STREIT AG GARDENSTADTSTRASSE 10
KOENIZ, BERN CH-3098
K082891 HAAG-STREIT AG 1667 RIDGEWOOD ROAD
WADSWORTH OH 44281
K100202 HAAG-STREIT AG GARTENSTADTSTRASSE 10
KOENIZ CH-3098
K073190 HUVITZ CO., LTD. 340 SHADY GROVE ROAD
FLINTVILLE TN 37335
K093639 HUVITZ CO., LTD. 136 W. ORION
TEMPE AZ 85283
K133062 INNOVATIVE VISUAL SYSTEMS 386 NORTH YORK RD SUITE 209
ELMHURST IL 60126
K092883 INTRAVISTA MEDICAL SYSTEMS INC 1567 SAMEDRA ST
SUNNYVALE CA 94087
K973064 KEELER INSTRUMENTS, INC. 456 PKWY.
BROOMALL PA 19008
K100500 KEELER INSTRUMENTS, INC. 456 PKWY.
BROOMALL PA 19008
K151394 KEELER LIMITED CLEWER HILL ROAD
WINDSOR SL4 4AA
K140451 KEELER LIMITED 456 PARKWAY
BROOMALL PA 19008
K131589 KEELER LTD. CLEWER HILL RD.
WINDSOR, BERKSHIRE SL4 4AA
K810403 KEELER OPTICAL PRODUCTS LTD.
K063640 KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO
CHUO-KU, TOKYO 103-8433
K133755 KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO
CHUO-KU, TOKYO 103-8433
K954782 KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W.
WASHINGTON DC 20005
K880920 KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE.
TORRANCE CA 90502
K913852 KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE.
TORRANCE CA 90502
K951054 LEICA, INC. P.O. BOX 123
BUFFALO NY 14240 0123
K811153 LUMENIS, INC.
K930438 MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY.
JACKSONVILLE FL 32224
K170470 Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II
Hsinchu 30076
K193188 Medimaging Integrated Solution Inc. (MiiS) 3F.,No.24-2, Industry E. Rd. IV, Hsinchu Science Park
Hsinchu 30077
K802355 METRICON, LTD.
K832911 MIAMI EYE TECHNOLOGY, INC.
K863970 MLC TECHNOLOGIES 90 GROVE ST.
RIDGEFIELD CT 06877
K953030 NAVEEN INTL., INC. 193 ROCK RIDGE RD.
MILLERSVILLE MD 21108
K951340 NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO,
TOKYO
K951341 NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO,
TOKYO
K133132 NIDEK CO., LTD. 755 N. MATHILDA AVENUE
SUNNYVALE CA 94085
K163564 NIDEK CO., LTD. 34-14 Maehama, Hiroishicho
Gamagori 443-0038
K012416 NIDEK TECHNOLOGIES SRL 21911 ERIE LN.
LAKE FOREST CA 92630
K874220 OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY
BELLEVUE WA 98005
K915356 OCULON CORP. BOX 3538, R.F.D.
LONG GROVE IL 60047
K861854 OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU
CHIYODA-KU TOKYO JAPAN
K863048 OPTEK MEDICO CO., LTD. RM.#1108, AL BERGO OCHANOMIZU
CHIYODA-KU TOKYO JAPAN
K951184 OTI MEDICAL LLC. 530 BERCUT DR.
SACRAMENTO CA 95814
K962522 PACIFIC OPHTHALMIC SUPPLY 1920 OAK KNOLL DR.
BELMONT CA 94002
K924770 R.H. BURTON CO. 3965 BROOKHAM DR.
GROVE CITY OH 43123
K924787 R.H. BURTON CO. 3965 BROOKHAM DR.
GROVE CITY OH 43123
K924782 R.H. BURTON CO. 3965 BROOKHAM DR.
GROVE CITY OH 43123
K924783 R.H. BURTON CO. 3965 BROOKHAM DR.
GROVE CITY OH 43123
K063750 REICHERT INC. 3362 WALDEN AVE.
DEPEW NY 14043
K061330 REICHERT, INC. 3374 WALDEN AVE.
DEPEW NY 14043
K141954 REICHERT, INC. 3362 WALDEN AVE.
DEPEW NY 14043
K110129 RIGHTMEDICAL PRODUCTS, LLC 1430 BIRCHMOUNT ROAD
TORONTO, ONTARIO M1P 2E8
K060869 RIGHTMEDICAL PRODUCTS, LLC 200 EXPRESSWAY COURT
VIRGINIA BEACH VA 23462
K100439 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. 1485 ANDREW DR
CLAREMONT CA 91711
K152429 SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. Zone A, 2nd Floor, No. 69, Lane
SHANGHAI 200237
K153545 SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. NO.29, Jiuyuan Road, Qingpu Industrial Park, Shanghai,
Shanghai 201700
K910980 SITE MICROSURGICAL SYSTEMS, INC. 135 GIBRALTAR RD.
HORSHAM PA 19044
K131711 SUZHOU 66 VISION TECH CO., LTD. NO. 34 DARU LANE
SUZHOU, JIANGSU 215005
K033190 SUZHOU 66 VISION-TECH CO., LTD 6833 SAINT LAWRENCE STREET
PLANO TX 75024
K162778 SUZHOU KANGJIE MEDICAL INC No. 129, Weixin Rd., Weiting Town
Suzhou 215000
K063352 TAKAGI SEIKO CO., LTD. 82 GILBERT STREET
ADELAIDE, SOUTH AUSTRALIA 5000
K152535 TAKAGI SEIKO CO., LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN
NAGANO 383-8585
K162636 TAKAGI SEIKO CO.LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN
NAKANO 383-8585
K930518 TALIA TECHNOLOGY LTD. COLUMBIA SQUARE
WASHINGTON DC 20004 1109
K912514 TANDEM SCANNING CORP. 4903 SANGAMORE RD.
BETHESDA MD 20816
K971953 TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR
CAMBRIDGE MA 02139
K944910 TOMEY CORPORATION USA 15825 SHADY GROVE ROAD
ROCKVILLE MD 20850
K133667 TOPCON CORP. 5 TIMBER LANE
NORTH READING MA 01864
K161972 TOPCON CORPORATION 75-1 HASUNUMA-CHO, ITABASHIL-KU
TOKYO 174-8580
K110489 TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE
NORTH READING MA 01864
K063416 U.S. OPHTHALMIC LLC 7255 NW 68 ST. UNIT #9
MIAMI FL 33166
K080776 USOPHTHALMIC, LLC 7255 NW 88TH STREET
MIAMI FL 33166
K093021 USOPTHALMIC, LLC 19526 EAST LAKE DR.
MIAMI FL 33015-2218
K160327 VISIA IMAGING S.R.L VIA MARTIRI DELLA LIBERTA 95/E
San Giovanni Valdarno 52027
K131567 VISIA imaging S.r.l. 110 EAST GRANADA BLVD, STE 209
ORMOND BEACH FL 32176
K043503 VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY
SANTA CLARA CA 95051-0703
K900477 WOODLYN, INC. 2920 MALMO DR.
ARLINGTON HEIGHTS IL 60005 4726
K900476 WOODLYN, INC. 2920 MALMO DR.
ARLINGTON HEIGHTS IL 60005 4726




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