FDA 510(k) Applications for Medical Device:
Accessories, Soft Lens Products
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093254 | ABBOTT MEDICAL OPTICS INC |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705 |
| K032030 | ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705-4933 |
| K030092 | ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705-4933 |
| K042562 | ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE | SANTA ANA | CA | 92705-4933 |
| K032481 | ADVANCED VISION RESEARCH, INC. |
269A BALLARDVALE STREET | WILMINGTON | MA | 01887 |
| K981574 | ALCON |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K973332 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K974624 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K981561 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K983780 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K984575 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K984573 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K974625 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K990480 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K981151 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K983973 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K191795 | Alcon Laboratories, Inc. |
6201 South Freeway | Fort Worth | TX | 76134-2099 |
| K162597 | Alcon Laboratories, Inc. |
6201 South Freeway | Fort Worth | TX | 76134-2099 |
| K142284 | ALCON LABORATORIES, INC. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134 |
| K102860 | ALCON RESEARCH, LTD. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K050729 | ALCON RESEARCH, LTD. |
6201 SOUTH FREEWAY R7-20 | FORT WORTH | TX | 76134 |
| K001214 | ALCON UNIVERSAL, LTD. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K002589 | ALCON UNIVERSAL, LTD. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K021143 | ALCON UNIVERSAL, LTD. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K071236 | ALCON, INC. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K031193 | ALCON, INC. |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K190674 | Allergan, Inc |
2525 Dupont Drive | Irvine | CA | 92623-9534 |
| K000164 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K003109 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K983150 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K013479 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92612 |
| K014202 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92612 |
| K003252 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K980775 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K981168 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K992028 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K083812 | ALLERGAN, INC. |
269A BALLARDVALE STREET | WILMINGTON | MA | 01887 |
| K984383 | ALLERGAN, INC. |
2525 DUPONT DR. | IRVINE | CA | 92623-9534 |
| K003031 | ALPHA VISTA, INC. |
42 DIGITAL DR., SUITE 12 | NOVATA | CA | 94949 |
| K062332 | ALTAIRE PHARMACEUTICALS, INC. |
GRAND VALLEY BUSINESS PLAZA | GRAND JUNCTION | CO | 81505 |
| K980147 | AUTOMATIC LIQUID PACKAGING, INC. |
203 NORTH WABASH, SUITE 1200 | CHICAGO | IL | 60601 |
| K202932 | Bausch & Lomb Incorporated |
1400 North Goodman Street | Rochester | NY | 14609 |
| K132216 | BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609 |
| K222541 | Bausch & Lomb Incorporated |
1400 N Goodman Street | Rochester | NY | 14609 |
| K170483 | Bausch & Lomb Incorporated |
1400 North Goodman Street | Rochester | NY | 14609 |
| K161819 | Bausch & Lomb Incorporated |
1400 North Goodman Street | Rochester | NY | 14609 |
| K031646 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K000247 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K983225 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14692-0450 |
| K982775 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14692-0450 |
| K973921 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K111877 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K112909 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K980591 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K002823 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K001539 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K974723 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K990422 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K011796 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K093367 | CACHET PHARMACEUTICALS PVT. LTD. |
415 SHAH NAHAR, WORLI | MUMBAI | 400 018 | |
| K102165 | CACHET PHARMACEUTICALS PVT. LTD. |
415 SHAH NAHAR, WORLI | MUMBAI | 400 018 | |
| K221263 | Chemtex USA Inc. |
27-29 Dwight Place | Fairfield | NJ | 07004-3303 |
| K193441 | Chemtex USA, Inc. |
27-29 Dwight Place | Fairfield | NJ | 07004-3303 |
| K013512 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K030522 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K031521 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K003345 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K042176 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PARKWAY | DULUTH | GA | 30097 |
| K033608 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K050250 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PARKWAY | DULUTH | GA | 30097 |
| K021635 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K031753 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K031957 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K982168 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K991403 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K012731 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K031522 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. | DULUTH | GA | 30097 |
| K030910 | CLUED UP LIMITED |
135 HIGH ST. | EGHAM, SURREY | TW20 9HL | |
| K070767 | LAPIS LAZULI INTERNATIONAL NV |
2214 SANFORD DRIVE SUITE B7 | GRAND JUNCTION, | CO | 81503 |
| K051104 | LAPIS LAZULI, NV |
623 GLACIER DRIVE | GRAND JUNCTION | CO | 81503 |
| K990044 | LOBOB LABORATORIES, INC. |
2000 M ST. NW # 700 | WASHINGTON | DC | 20036-3307 |
| K191872 | Menicon Co., Ltd. |
21-19, Aoi 3, Naka-ku | Nagoya | 460-0006 | |
| K151768 | MENICON CO.,LTD. |
21-19, AOI 3-CHOME, NAKA-KU | NAGOYA | 460-0006 | |
| K110221 | OPTICS LABORATORY, INC |
9480 TELSTAR AVE | EL MONTE | CA | 91731-2988 |
| K041008 | OPTICS LABORATORY, INC. |
5408 INTERSTATE DRIVE | SHREVEPORT | LA | 71109 |
| K161622 | Optics Laboratory, Inc. |
9480 Telstar Ave Suite 3 | El Monte | CA | 91731-2988 |
| K071203 | OPTIKEM INTERNATIONAL, INC. |
2214 SANFORD DRIVE UNIT B7 | GRAND JUNCTION | CO | 81505 |
| K000998 | OPTISONIC, INC. |
203 NORTH WABASH AVE. | CHICAGO | IL | 60601 |
| K210051 | OTE North America LLC |
40 Bayview Ave | Inwood | NY | 11096 |
| K991620 | PFIZER, INC. |
235 EAST 42ND ST. | NEW YORK | NY | 10017 |
| K980133 | POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. | ROCHESTER | NY | 14692 |
| K973217 | POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. | ROCHESTER | NY | 14692 |
| K002319 | PURILENS, INC. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K991125 | SAUFLON PHARMACEUTICALS, LTD. |
203 N. WABASH AVE. | CHICAGO | IL | 60601 |
| K010559 | SAUFLON PHARMACEUTICALS, LTD. |
49-53 YORK ST. | TWICKENHAM, MIDDLESEX | TW1-3LP | |
| K130734 | SAUFLON PHARMACEUTICALS, LTD. |
49-53 YORK ST. | TWICKENHAM, MIDDLESEX | TW1-3LP | |
| K030278 | SAUFLON PHARMACEUTICALS, LTD. |
49-53 YORK ST. | TWICKENHAM, MIDDLESEX | TW1-3LP | |
| K974485 | SZABOCSIK AND ASSOC. |
203 N WABASH, STE 1200 | CHICAGO | IL | 60601 |
| K060924 | SZABOCSIK AND ASSOCIATES |
203 NORTH WABASH AVE STE 1200 | CHICAGO | IL | 60601 |
| K050517 | SZABOCSIK AND ASSOCIATES |
203 N.WABASH, SUITE 1200 | CHICAGO | IL | 60601 |
| K200747 | The LifeStyle Company, Inc. |
6 Paragon Way Suite 112 | Freehold | NJ | 07728 |
| K011561 | WILSA, INC. |
2172 SOUTH JASON ST. | DENVER | CO | 80223 |
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