FDA 510(k) Applications for Medical Device:
Laser, Ophthalmic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K981196 | AESCULAP-MEDITEC NORTH AMERICA |
23832 VIA MONTE | COTO DE CAZA | CA | 92679-4001 |
| K062624 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K990665 | AMERICAN LASER CORP. |
2417 SOUTH 3850 WEST | SALT LAKE CITY | UT | 84120 |
| K033941 | BAUSCH & LOMB, INC. |
3365 TREE CT. INDUSTRIAL BLVD. | ST. LOUIS | MO | 63122-6694 |
| K240615 | Beaver-Visitec International, Inc. |
10 CityPoint, 500 Totten Pond Rd | Waltham | MA | 02451 |
| K230722 | BELKIN Vision Ltd. |
13 Gan Rave Blvd. | Yavne | 8122214 | |
| K232051 | Carl Zeiss Meditec |
5300 Central Parkway | Dublin | CA | 94568 |
| K233911 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K181682 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07445 | |
| K103056 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K100253 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K230350 | Carl Zeiss Meditec Inc |
5300 Central Parkway | Dublin | CA | 94568 |
| K964751 | CERAMOPTEC, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K222395 | Ellex Medical Pty Ltd |
3-4 Second Avenue Mawson Lakes | Adelaide | ||
| K212630 | Ellex Medical Pty Ltd |
3-4 Second Avenue Mawson Lakes | Adelaide | ||
| K122202 | Ellex Medical Pty. Ltd. |
82 GILBERT ST. | ADELAIDE, SOUTH AUSTRALIA | 5000 | |
| K142398 | Ellex Medical Pty. Ltd. |
82 GILBERT ST. | ADELAIDE | 5000 | |
| K081565 | Ellex Medical Pty. Ltd. |
82 GILBERT ST. | ADELAIDE, SOUTH AUSTRALIA | 5000 | |
| K080423 | Ellex Medical Pty. Ltd. |
82 GILBERT ST. | ADELAIDE, SOUTH AUSTRALIA | 5000 | |
| K972514 | Ellex Medical Pty. Ltd. |
258 HALIFAX ST. | ADELAIDE, S.A. | 5000 | |
| K041598 | Ellex Medical Pty. Ltd. |
74 TO 86 GILBERT ST. | ADELAIDE, SOUTH AUSTRALIA | 5000 | |
| K133019 | EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM |
BEBEK YOLU SOKAGI 23/3 ETILER | ISTANBUL | 34337 | |
| K243014 | EyeQ Inc. |
8740 Technology Way | Reno | NV | 89521 |
| K973220 | G. RODENSTOCK INSTRUMENTE GMBH |
100 MAIN ST. SUITE 120 | CONCORD | MA | |
| K971950 | INFINITECH, INC. |
750 GODDARD AVE. | CHESTERFIELD | MO | 63005 |
| K960522 | IRIDERM DIV. |
340 PIONEER WAY | MOUNTAIN VIEW | CA | 94041-1506 |
| K960971 | IRIDERM DIV. |
340 PIONEER WAY | MOUNTAIN VIEW | CA | 94041-1506 |
| K062074 | IRIDEX CORP. |
1212 TERRA BELLA AVE. | MOUNTAIN VIEW | CA | 94043 |
| K040209 | IRIDEX CORP. |
1212 TERRA BELLA AVE. | MOUNTAIN VIEW | CA | 94043 |
| K031665 | IRIDEX CORP. |
1212 TERRA BELLA AVE. | MOUNTAIN VIEW | CA | 94043 |
| K020374 | IRIDEX CORP. |
1212 TERRA BELLA AVE. | MOUNTAIN VIEW | CA | 94043 |
| K230228 | Iridex Corporation |
1212 Terra Bella Ave. | Mountain View | CA | 94043 |
| K202760 | Iridex Corporation |
1212 Terra Bella Ave. | Mountain View | CA | 94043 |
| K213592 | Iridex Corporation |
1212 Terra Bella Ave. | Mountain View | CA | 94043 |
| K223132 | Iridex Corporation |
1212 Terra Bella Ave. | Mountain View | CA | 94043 |
| K121187 | KATALYST SURGICAL, LLC |
1331 H ST NW, 12TH FL | WASHINGTON | DC | 20005 |
| K140362 | KATALYST SURGICAL, LLC |
754 Goddard Ave | Chesterfield | MO | 63005 |
| K990075 | LIGHT-MED (USA), INC. |
110P VIA ESTRADA | LAGUNA HILLS | CA | 92653 |
| K190448 | Light-Med(USA), INC. |
1130 Calle Cordillera | San Clemente | CA | 92673 |
| K010372 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | SHULIN CITY | 238 | |
| K063297 | LIGHTMED CORP. |
437 HILLSIDE AVENUE | BEN LOMOND | CA | 95005 |
| K091981 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | TAIPEI | 238 | |
| K021538 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | SHULIN CITY | 238 | |
| K124043 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | NEW TAIPEI CITY | 23861 | |
| K091534 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | TAIPEI | 238 | |
| K103547 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | SHULIN CITY | 238 | |
| K090774 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | SHULIN CITY | 238 | |
| K142172 | LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 | NEW TAIPEI CITY | 23861 | |
| K152688 | LIGHTMED CORPORATION |
No. 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist | New Taipei City | 23861 | |
| K220877 | Lumenis Be, Inc. |
1870 South Milestone Drive | Salt Lake City | UT | 84104 |
| K051944 | LUMENIS, INC. |
2400 CONDENSA ST. | SANTA CLARA | CA | 95051-0901 |
| K130195 | LUMENIS, INC. |
3959 WEST 1820 SOUTH | SALT LAKE CITY | UT | 84104 |
| K153769 | Lutronic Corporation |
219, Sowon-ro, Deogyang-gu | Goyang-si | 410-220 | |
| K220974 | Lutronic Vision, Inc. |
19 Fortune Drive | Billerica | MA | 01821 |
| K973193 | LUXTEC CORP. |
45 PONTIAC RD. | NEWTON | MA | 02168 |
| K231011 | Meridian AG |
Bierigutstrasse 7 | Thun | CH-3608 | |
| K072823 | MERIDIAN AG |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K232417 | Meridian AG |
Bierigutstrasse 7 | Thun | CH-3608 | |
| K133358 | NIDEK CO., LTD |
VIA DELL'ARTIGIANATO, 6/A | ALBIGNASEGO | 35020 | |
| K152603 | NIDEK CO., LTD. |
34-14 MAEHAMA, HIROISHICHO | GAMAGORI | 443-0038 | |
| K203130 | Nidek Co., Ltd. |
34-14 Machama, Hiroishicho | Gamagori | 443-0038 | |
| K192045 | Nidek Co., Ltd. |
34-14 Maehama, Hiroishicho | Gamagori | 443-0038 | |
| K170302 | NIDEK CO., LTD. |
34-14 Maehama, Hiroishicho | Gamagori | 443-0038 | |
| K013760 | NIDEK, INC. |
21911 ERIE LN. | LAKE FOREST | CA | 92630 |
| K222157 | Norlase |
Brydehusvej 13 | Ballerup | DK-2750 | |
| K190083 | Norlase ApS |
Brydehusvej 302750 | Ballerup | ||
| K201623 | Norlase ApS |
Brydehusvej 30 | 2750 Ballerup | ||
| K242397 | Norlase Aps |
Brydehusvej 13 | Ballerup | 2750 | |
| K091064 | OD -OS GMBH |
733 BOLSANA DRIVE | LAGUNA BEACH | CA | 92651 |
| K050541 | OMNIGUIDE COMMUNICATIONS, INC. |
ONE KENDALL SQUARE, BLDG 100 | CAMBRIDGE | MA | 02139 |
| K050807 | OPHTHALMED LLC |
1308 MORNINGSIDE PARK DR. | ALPHARETTA | GA | 30022 |
| K142830 | OPHTHALMED LLC |
1050 Northfield Ct Ste 280 | ROSWELL | GA | 30076 |
| K100019 | OPTIMEDICA CORPORATION |
155-A MOFFETT PARK DRIVE | SUNNYVALE | CA | 94089 |
| K111643 | OPTO ELECTRONICA SA |
JOAQUIM A.R. DE SOUZA ST. | SAO CARLOS, SAO PAULO | 13.563-330 | |
| K111460 | OPTO ELETRONICA S/A |
JOAQUIM A. R. DE SOUZA STREET | SAO CARLOS, SAO PAULO | 13630-330 | |
| K031023 | PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. | NEW BRITAIN | PA | 18901 |
| K061024 | PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. | NEW BRITAIN | PA | 18901 |
| K220430 | Quantel Medical |
1 Rue du Bois Joli-CS40015 | Cournon D'Auvergne-Cedex | 63808 | |
| K170067 | Quantel Medical |
11 rue Bois Joli, CS40015 | Cournon D'Auvergne-Cedex | 63808 | |
| K043236 | QUANTEL MEDICAL |
342 SUNSET BAY RD. | HOT SPRINGS | AR | 71913 |
| K023094 | QUANTEL MEDICAL |
342 SUNSET BAY RD. | HOT SPRINGS | AR | 71913 |
| K140336 | QUANTEL MEDICAL |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K043613 | QUANTEL MEDICAL |
342 SUNSET BAY RD. | HOT SPRINGS | AR | 71913 |
| K130933 | QUANTEL MEDICAL |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K091581 | QUANTEL MEDICAL |
21 RUE NEWTON - ZONE DU BREZET | CLERMONT-FERRAND | 63039 | |
| K070776 | QUANTEL MEDICAL |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K120825 | QUANTEL MEDICAL |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K081946 | QUANTEL MEDICAL |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K201502 | Quantel Medical |
11 Rue du Bois Joli-CS40015 | Cournon D'Auvergne-Cedex | 63808 | |
| K112154 | SIE AG,SURGICAL INSTUMENT ENGINEERING |
5401 S. COTTONWOOD CT. | GREENWOOD VILLAGE | CO | 80121 |
| K081774 | SOLX INC. |
890 WINTER ST., SUITE 115 | WALTHAM | MA | 02451 |
| K131207 | SURGICAL INSTRUMENT ENGINEERING AG |
33 Golden Eagle Lane | Littleton | CO | 80127 |
| K001772 | TARACAN PTY. LTD. |
258 HALIFAX ST. | ADELAIDE, SOUTH AUSTRALIA | 5000 | |
| K111108 | TOPCON MEDICAL LASER SYSTEMS, INC |
3130 CORONADO DRIVE | SANTA CLARA | CA | 95054 |
| K092621 | TOPCON MEDICAL LASER SYSTEMS, INC |
3130 CORONADO DRIVE | SANTA CLARA | CA | 95054 |
| K123542 | TOPCON MEDICAL LASER SYSTEMS, INC |
2800 PLEASANT HILL RD., | PLEASANT HILL | CA | 94553 |
| K171488 | Topcon Medical Laser Systems, Inc. |
606 Enterprise Ct. | Livermore | CA | 94550 |
| K180402 | Topcon Medical Laser Systems, Inc. |
606 Enterprise Ct. | Livermore | CA | 94550 |
| K123056 | TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) |
2800 PLEASANT HILL RD | PLEASANT HILL | CA | 94523 |
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