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 | |
| K012873 | BAUSCH & LOMB, INC. |
9342 JERONIMO RD. | IRVINE | CA | 92618 |
| 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 |
| 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 | |
| K970414 | CON-S LTD. |
ONE GALLERIA BOULEVARD, | METAIRIE | LA | 70002 |
| K992836 | CSO |
197 BELVOIR RD. | WILLIAMSVILLE | NY | 14221 |
| K231760 | Cylite Pty Ltd |
300 Wellington Road | Mulgrave | 3170 | |
| 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 | |
| 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 | |
| K222372 | Kowa Company, Ltd. |
3-1, Chofugaoka 3-Chome | Chofu-shi | 1820021 | |
| 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 | |
| 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 |
| K962522 | PACIFIC OPHTHALMIC SUPPLY |
1920 OAK KNOLL DR. | BELMONT | CA | 94002 |
| 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 | |
| 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 | |
| K971953 | TOMEY CORPORATION USA |
325 VASSAR ST. 2ND FLOOR | CAMBRIDGE | MA | 02139 |
| 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 |
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