FDA 510(k) Applications for Medical Device:
Lens, Contact (Other Material) - Daily
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K230910 |
Acculens, Inc. |
5353 West Colfax Avenue
| Lakewood |
CO |
80214 |
K162005 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K230965 |
Acuity Polymers, Inc. |
1667 Lake Ave
| Rochester |
NY |
14615 |
K163254 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K180988 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K203571 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K213538 |
Acuity Polymers, Inc. |
1667 Lake Ave. Suite 303
| Rochester |
NY |
14615 |
K201194 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K170007 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K170001 |
Acuity Polymers, Inc. |
1667 Lake Avenue, Suite 354
| Rochester |
NY |
14615 |
K152724 |
ADVANCED VISION TECHNOLOGIES |
969 SOUTH KIPLING PARKWAY
| LAKEWOOD |
CO |
80226 |
K962934 |
AIRPERM, INC. |
4505 VAN NUYS BLVD.
| SHERMAN OAKS |
CA |
91403 |
K172314 |
Art Optical Contact Lens Inc |
3175 3 Mile Rd NW
| Grand Rapids |
MI |
49534 |
K022128 |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14609 |
K053124 |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14609 |
K013762 |
BAUSCH & LOMB INCORPORATED |
1400 N. GOODMAN ST.
| ROCHESTER |
NY |
14603-0450 |
K073184 |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14609-3547 |
K071266 |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14609-3547 |
K071043 |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14609-3547 |
K183167 |
Bausch & Lomb, Incorporated |
1400 North Goodman Street
| Rochester |
NY |
14609 |
K171404 |
BAUSCH + LOMB Incorporated |
1400 North Goodman Street
| Rochester NY |
NY |
14609 |
K963512 |
BENZ RESEARCH AND DEVELOPMENT CORP. |
611 EISENHAUER ST.
| GRAND JUNCTION |
CO |
81505 |
K963744 |
BENZ RESEARCH AND DEVELOPMENT CORP. |
611 EISENHAUER ST.
| GRAND JUNCTION |
CO |
81505 |
K153066 |
Boston Foundation for Sight |
464 Hillside Avenue, Suite 205
| Needham |
MA |
02494 |
K161461 |
BostonSight |
464 Hillside Avenue, Suite 205
| Needham |
MA |
02494 |
K183175 |
BostonSight |
464 Hillside Avenue, Suite 205
| Needham |
MA |
02494 |
K990895 |
CONCISE CONTACT LENS CO. |
2000 M ST. NW, SUITE 700
| WASHINGTON |
DC |
20036 |
K171575 |
CONTAMAC Ltd. |
Carlton House Shire Hill
| Saffron Walden |
|
CB11 3AU |
K171077 |
CONTAMAC Ltd. |
Carlton House Shire Hill
| Saffron Walden |
|
CB11 3AU |
K021977 |
CONTAMAC LTD. |
13 RED FOX LN.
| LITTLETON |
CO |
80127 |
K182304 |
CONTAMAC LTD. |
Carlton House Shire Hill
| Saffron Walden |
|
CB11 3AU |
K062548 |
CONTAMAC LTD. |
2214 SANFORD DRIVE
| GRAND JUNCTION |
CO |
81505 |
K033594 |
CONTAMAC LTD. |
623 GLACIER DR.
| GRAND JUNCTION |
CO |
81503 |
K070628 |
CONTAMAC LTD. |
2214 SANFORD DRIVE,SUITE B7
| GRAND JUNCTION |
CO |
81505 |
K180616 |
Contamac Ltd. |
Carlton House Shire Hall
| Saffron Walden |
|
CB11 3AU |
K161100 |
CONTAMAC LTD. |
CARLTON HOUSE SHIRE HILL
| SAFFRON WALDEN |
|
CB11 3AU |
K081178 |
CONTAMAC LTD. |
806 KIMBALL AVENUE
| GRAND JUNCTION |
CO |
81501 |
K212631 |
Contamac Ltd. |
Carlton House Shire Hill
| Saffron Walden |
|
CB11 3AU |
K181579 |
E&E Optics Inc. |
1795 E. Holt Blvd, Unit 104
| Ontario |
CA |
91761 |
K974636 |
FUTURISTIC DESIGN ASSOC. |
ONE AVALON RD.
| MOUNT VERNON |
OH |
43050 |
K991780 |
G.T. LABORATORIES, INC. |
203 NORTH WABASH AVE.
| CHICAGO |
IL |
60601 |
K991781 |
G.T. LABORATORIES, INC. |
203 NORTH WABASH AVE.
| CHICAGO |
IL |
60601 |
K000485 |
INNOVISION, INC. |
3125 SOUTH 61ST AVE.
| OMAHA |
NE |
68106-3675 |
K011914 |
INNOVISION, INC. |
3125 SOUTH 61ST AVE.
| OMAHA |
NE |
68106-3675 |
K020006 |
LENS DYNAMICS, INC. |
8600 WEST 14TH AVE., #2
| LAKEWOOD |
CO |
80215 |
K021752 |
LUCID KOREA CO., LTD |
748 KEOCHON-RI PONGHWA-EUP,
| KYUNGSANGBUK-PROVINCE |
|
|
K000233 |
MENICON CO. LTD. |
269A BALLARDVALE ST.
| WILMINGTON |
MA |
01887 |
K103561 |
MENICON CO. LTD. |
187 BALLARDVALE STREET
| WILMINGTON |
MA |
01887 |
K962006 |
MENICON CO. LTD. |
700 THIRTEENTH STREET, N.W.,
| WASHINGTON |
DC |
20005 |
K081443 |
MENICON CO. LTD. |
269A BALLARDVALE ST.
| WILMINGTON |
MA |
01887 |
K972443 |
MENICON U.S.A., INC. |
333 WEST PONTIAC WAY
| CLOVIS |
CA |
93612 |
K000133 |
MENICON U.S.A., INC. |
269 A BALLARDVALE ST.
| WILMINGTON |
MA |
01887 |
K990264 |
METRO OPTICS OF AUSTIN, INC. |
15802 VISION DR.
| PFLUGERVILLE |
TX |
78660 |
K024164 |
METRO OPTICS, INC. |
623 GLACIER DR.
| GRAND JUNCTION |
CO |
81503 |
K955900 |
NOVAVISION, INC. |
2700-200 GATEWAY CENTRE BLVD.
| MORRISVILLE |
NC |
27560 |
K960584 |
NOVAVISION, INC. |
2700-200 GATEWAY CENTRE BLVD.
| MORRISVILLE |
NC |
27560 |
K002703 |
OPTICAL POLYMER RESEARCH, INC. |
5921 N.E. 38TH ST.
| GAINESVILLE |
FL |
32609 |
K954124 |
OPTICAL POLYMER RESEARCH, INC. |
235 NORTH TALBOT CT.
| ROSWELL |
GA |
30076-2480 |
K052983 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K180172 |
Paragon Vision Sciences |
974 E Impala Ave
| Mesa |
AZ |
85204 |
K120996 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K070637 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K082799 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K002845 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K013310 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K984436 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K993586 |
PARAGON VISION SCIENCES |
947 EAST IMPALA AVE.
| MESA |
AZ |
85204 |
K221768 |
Paragon Vision Sciences, Inc. |
2120 W. Guadalupe Rd.
| Gilbert |
AZ |
52233 |
K963010 |
PERMEABLE TECHNOLOGIES, INC. |
6 SHADOWBROOK DR.
| COLTS NECK |
NJ |
07722 |
K003932 |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST.
| ROCHESTER |
NY |
14603-0450 |
K000795 |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K001960 |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K002025 |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K970698 |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K011945 |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K980741 |
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
1400 NORTH GOODMAN ST.
| ROCHESTER |
NY |
14692 |
K010454 |
PROGRESSIVE OPTICAL RESEARCH LTD. |
#20, 1410-40TH AVENUE, N.E.
| CALGARY, ALBERTA |
|
T2E 6L1 |
K955366 |
RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD., SUITE 9
| SACRAMENTO |
CA |
95834 |
K013646 |
ROSE K INTERNATIONAL LTD. |
60 ST. ANDREWS TCE
| HAMILTON |
|
|
K992787 |
SPECIALTY ULTRAVISION, INC. |
307 ORCHARD CITY DR.
| CAMPBELL |
CA |
95008 |
K980197 |
SPECIALTY ULTRAVISION, INC. |
307 ORCHARD CITY DR.
| CAMPBELL |
CA |
95008 |
K952260 |
STELLAR CONTACT LENS, INC. |
203 N. WABASH AVE, STE 1200
| CHICAGO |
IL |
60601 |
K051035 |
SYNERGEYES |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K052675 |
SYNERGEYES |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K061120 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K153714 |
Synergeyes, Inc. |
5927 PRIESTLY DR SUITE210
| CARLSBAD |
CA |
92008 |
K081034 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K080193 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K060102 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K083921 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K113586 |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD
| ROCKVILLE |
MD |
20850 |
K160938 |
SynergEyes, Inc. |
5927 PRIESTLY DR, SUITE210
| CARLSBAD |
CA |
92008 |
K142510 |
Synergeyes, Inc. |
2232 Rutherford Road
| Carlsbad |
CA |
92008 |
K033599 |
THE LAGADO CORP. |
203 NORTH WABASH AVENUE
| CHICAGO |
IL |
60601 |
K052507 |
THE LAGADO CORP. |
203 NORTH WABASH AVENUE
| CHICAGO |
IL |
60601 |
K102154 |
THE LAGADO CORP. |
203 NORTH WABASH,
| CHICAGO |
IL |
60601 |
K213880 |
Valley Contax, Inc. |
200 South Mill St.
| Springfield |
OR |
97477 |
K170335 |
Valley Contax, Inc. |
200 S Mill St
| Springfield |
OR |
97477 |
K202860 |
Valley Contax, Inc. |
200 S Mill St.
| Springfield |
OR |
97477 |
K223394 |
Visionary Optics LLC |
1325 Progress Drive
| Front Royal |
VA |
22630 |
K171950 |
Visionary Optics LLC |
1325 Progress Drive
| Front Royal |
VA |
22630 |
|
|