FDA 510(k) Applications for Medical Device:
Unit, Phacofragmentation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K002986 | A.R.C. LASER AG |
2417 SOUTH 3850 WEST | SALT LAKE CITY | UT | 84120 |
| K003512 | A.R.C. LASER AG |
2417 SOUTH 3850 WEST | SALT LAKE CITY | UT | 84120 |
| K111697 | ABBOTT MEDICAL OPTICS INC |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K151636 | ABBOTT MEDICAL OPTICS INC |
1700 EAST ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K133115 | ABBOTT MEDICAL OPTICS INC |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K111882 | ABBOTT MEDICAL OPTICS INC |
1700 EAST SAINT ANDREW PL | SANTA ANA | CA | 92705 |
| K121721 | ABBOTT MEDICAL OPTICS INC |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K111446 | ABBOTT MEDICAL OPTICS INC |
1700 EAST SAINT ANDREW PL | SANTA ANA | CA | 92705 |
| K103023 | ABBOTT MEDICAL OPTICS INC |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K151783 | Abbott Medical Optics Inc. |
1700 East St. Andrew Place | Santa Ana | CA | 92705 |
| K160236 | Abbott Medical Optics Inc. |
1700 East Saint Andrew Place | Santa Ana | CA | 92705 |
| K050648 | ADVANCED MEDICAL OPTICS, INC. |
1700 EAST ST. ANDREW PL. | SANTA ANA | CA | 92705 |
| K060366 | ADVANCED MEDICAL OPTICS, INC. |
1700 EAST ST. ANDREW PL. | SANTA ANA | CA | 92799 |
| K063583 | ALCON |
6201 SOUTH FREEWAY, R7-20 | FORT WORTH | TX | 76134-2099 |
| K955789 | ALCON LABORATORIES |
6201 S FREEWAY | FT WORTH | TX | 76134 |
| K981103 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K233876 | Alcon Laboratories Inc. |
6201 South Freeway | Fort Worth | TX | 76134 |
| K121555 | ALCON LABORATORIES, INC. |
15800 ALTON PARKWAY | IRVINE | CA | 92623 |
| K233902 | Alcon Laboratories, Inc. |
6201 South Freeway | Fort Worth | TX | 76134 |
| K021566 | ALCON LABORATORIES, INC. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K120732 | ALCON LENSX, INC. |
733 BOLSANA DRIVE | LAGUNA BEACH | CA | 92651 |
| K093210 | ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. | IRVINE | CA | 92618-3818 |
| K101285 | ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. | IRVINE | CA | 92618-3818 |
| K112425 | ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. | IRVINE | CA | 92618-3818 |
| K120912 | ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. | IRVINE | CA | 92618-3818 |
| K191650 | Alcon Research, LLC |
6201 South Freeway | Fort Worth | TX | 76134 |
| K091777 | ALCON RESEARCH, LTD. |
15800 ALTON PARKWAY | IRVINE | CA | 92618 |
| K161794 | Alcon Research, Ltd. |
6201 SOUTH FREEWAY DR. | FORT WORTH | TX | 76134-2099 |
| K082845 | ALCON RESEARCH, LTD. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K971186 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92612 |
| K962402 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92612 |
| K003638 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K020527 | AMERICAN OPTISURGICAL, INC. |
25501 ARCTIC OCEAN | LAKE FOREST | CA | 92630 |
| K080803 | AMERICAN OPTISURGICAL, INC. |
25501 ARCTIC OCEAN | LAKE FOREST | CA | 92630 |
| K002031 | ASCLEPION-MEDITEC AG |
2525 MC GAW AVE. | IRVINE | CA | 92623-9791 |
| K133486 | BAUSCH & LOMB |
3365 TREE CT. INDUSTRIAL BLVD | ST. LOUIS | MO | 63122 |
| K133242 | BAUSCH & LOMB |
3365 TREE COURT INDUSTRIAL BLV | ST LOUIS | MO | 63122 |
| K082132 | BAUSCH & LOMB, INC |
1400 North Goodman Street | Rochester | NY | 14609 |
| K063331 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K082473 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K041998 | BAUSCH & LOMB, INC. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K101325 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K073023 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K033653 | BAUSCH & LOMB, INC. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K170052 | Bausch + Lomb |
3365 Tree Ct. Industrial Blvd | St. Louis | MO | 63122 |
| K162342 | Bausch + Lomb |
3365 Tree Ct. Industrial Blvd. | St. Louis | MO | 63122 |
| K232084 | Bausch and Lomb |
3365 Tree Ct. Industrial Blvd. | St. Louis | MO | 63122 |
| K240169 | Bausch and Lomb Incorporated |
3365 Tree Court Industrial Boulevard | St. Louis | MO | 63122 |
| K022833 | BENJAMIN BIOMEDICAL, INC. |
962 ALLEGRO LN. | APOLLO BEACH | FL | 33572 |
| K212241 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K230858 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K193376 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K200584 | Carl Zeiss Meditec Cataract Technology Inc |
8748 Technology Way | Reno | NV | 89521 |
| K242801 | Carl Zeiss Meditec Cataract Technology Inc. |
8740 Technology Way | Reno | NV | 89521 |
| K214028 | Carl Zeiss Meditec Cataract Technology Inc. |
8748 Technology Way | Reno | NV | 89521 |
| K222236 | Carl Zeiss Meditec Cataract Technology Inc. |
8748 Technology Way | Reno | NV | 89521 |
| K191024 | Carl Zeiss Meditec Cataract Technology Inc. |
8748 Technology Way | Reno | NV | 89521 |
| K200207 | Carl Zeiss Meditec Cataract Technology Inc. |
8748 Technology Way | Reno | NV | 89521 |
| K960414 | CHIRON VISION CORP. |
555 W. ARROW HWY. | CLAREMONT | CA | 91711 |
| K981989 | CIRCUIT TREE |
25707N COMPASS WAY | SAN JUAN CAPISTRANO | CA | 92675 |
| K962431 | CIRCUIT TREE MEDICAL, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780-3139 |
| K962430 | CIRCUIT TREE MEDICAL, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780-3139 |
| K213467 | D.O.R.C. Dutch Ophthalmic Research Center (International) |
B.V. | Zuidland | 3214 VN | |
| K190875 | D.O.R.C. Dutch Ophthalmic Research Center (International) |
B.V. | Zuidland | 3214 VN | |
| K965127 | DGH TECHNOLOGY, INC. |
110 SUMMIT DR., SUITE B | EXTON | PA | 19341 |
| K081877 | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEG 2 | ZUIDLAND | 3214 VN | |
| K142877 | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
SCHEIJDELVEWEG 2 | ZUIDLAND | 3214 VN | |
| K984143 | FIBRA SONICS, INC. |
5312 N. ELSTON AVE. | CHICAGO | IL | 60630 |
| K961658 | INTL. OPHTHALMIC INDUSTRIES CORP. |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632 |
| K191933 | Johnson & Johnson Surgical Vision, Inc. |
1700 East Saint Andrew Place | Santa Ana | CA | 92705 |
| K203060 | Johnson & Johnson Surgical Vision, Inc. |
1700 East St. Andrew Place | Santa Ana | CA | 92705 |
| K122829 | LENSAR, INC. |
2800 DISCOVERY DRIVE | ORLANDO | FL | 32826 |
| K091915 | LENSTEC, INC. |
1765 COMMERCE AVE N | ST. PETERSBURG | FL | 33716 |
| K974469 | MENTOR CORP. |
5425 HOLLISTER AVE. | SANTA BARBARA | CA | 93111 |
| K955245 | MENTOR O & O, INC. |
3000 LONGWATER DR. | NORWELL | MA | 02061-1672 |
| K002812 | MICHAEL REYNARD, M.D. |
1301-20TH ST., #260 | SANTA MONICA | CA | 90404 |
| K964018 | MICHAEL REYNARD, M.D. |
1301-20TH ST., #260 | SANTA MONICA | CA | 90404 |
| K030957 | MILVELLA PTY. LTD. |
2 DELPHINUS | IRVINE | CA | 92612 |
| K960287 | NIDEK, INC. |
47651 WESTINGHOUSE DR. | FREMONT | CA | 94539 |
| K972253 | ODYSSEY TECHNOLOGIES, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780 |
| K972252 | ODYSSEY TECHNOLOGIES, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780 |
| K133562 | OERTLI INSTRUMENTE AG |
HAFNERWISENSTRASSE 4 | BERNECK | 9442 | |
| K233398 | Oertli Instrumente AG |
Hafnerwiesenstrasse 4 | Berneck | 9442 | |
| K971795 | PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH | SALT LAKE CITY | UT | 84119 |
| K974719 | PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH | SALT LAKE CITY | UT | 84119 |
| K981109 | PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH | SALT LAKE CITY | UT | 84119 |
| K031404 | PHACOR INC., A SANTEN COMPANY |
775 FIERO LN. | SAN LUIS OBISPO | CA | 93401 |
| K192418 | Raico LLC |
26 Plaza Dr | Westmont | IL | 60559 |
| K960811 | SAINT JOHN'S PLAZA MEDICAL GROUP |
1301 20TH ST. #260 | SANTA MONICA | CA | 90404 |
| K973749 | SCIERAN TECHNOLOGIES, INC. |
27071 CABOT RD., SUITE 127 | LAGUNA HILLS | CA | 92653 |
| K980085 | SCIERAN TECHNOLOGIES, INC. |
27071 CABOT RD., SUITE 127 | LAGUNA HILLS | CA | 92653 |
| K020734 | STAAR SURGICAL CO. |
1911 WALKER AVE. | MONROVIA | CA | 91016 |
| K961310 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K962131 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K960003 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K960024 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K955901 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K961820 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K961874 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K961831 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K971439 | STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K961243 | SURGICAL DESIGN CORP. |
1050 CONNECTICUT AVENUE, NW | WASHINGTON | DC | 20036-5339 |
| K991852 | SURGICAL DESIGN CORP. |
1050 CONNECTICUT AVENUE, NW | WASHINGTON | DC | 20036-5339 |
| K002932 | SYNTEC, INC. |
733 MANSION RD. | WINFIELD | MO | 63389 |
| K980480 | SYNTEC, INC. |
743 SPIRIT 40 PARK DRIVE, | CHESTERFIELD | MO | 63005 |
| K051186 | TRILLIUM MEDICAL, INC. |
P.O. BOX 2601 | POULSBO | WA | 98370 |
| K954746 | U.S. IOL, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91789 |
| K971064 | VISION CARE DEVICES, INC. |
1246 REDWOOD BLVD. | REDDING | CA | 96003 |
| K971750 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K972063 | WILLIAM F. WHITTINGHAM |
22 FLORES | FOOTHILL RANCH | CA | 92610 |
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