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Miscellaneous
OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
K
95
5777
PMMA CLASIC
U
Cleared 510(K)
K
94
0106
KERATOPLASTY SUTURING LENS
U
Cleared 510(K)
K
91
3081
MULTI-VIEW BIFOCALS
U
Cleared 510(K)
K
89
7021
MARTIN-HENSLEY SEGMENT LENS
U
Cleared 510(K)
K
89
5411
OPTIKEM PMMA CONTACT LENS
U
Cleared 510(K)
K
87
4591
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
U
Cleared 510(K)
K
86
5111
CHARTER HARD CONTACT LENS CLEANING SOLUTION
U
Cleared 510(K)
K
86
4343
BL1 (HARD CONTACT LENS)
U
Cleared 510(K)
K
86
3974
CHARTER LABORATORIES INC. LENS LUBRICANT
U
Cleared 510(K)
K
86
2952
CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES
U
Cleared 510(K)
P
82
0065
BOSTON LENS II & IV
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
U
PMA Approval
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV
U
PMA Approval
P
82
0065
BOSTON LENS II & IV
U
PMA Approval
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) BROWN ,GRAY TINT
U
PMA Approval
P
82
0065
BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
89
0020
FLUOROCON TM-60
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0061
PARAPERM O2 CONTACT LENS CLEAR & BLUE
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
U
PMA Approval
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
87
0009
3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A)
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
U
PMA Approval
P
83
0050
B&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
85
0008
THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
K
86
2811
AQUALUX LENS CASE
U
Cleared 510(K)
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
K
86
1643
STYLEKEEPER CONTACT LENS CARRYING CASE
U
Cleared 510(K)
K
86
1712
WETTING & SOAKING HARD CONTACT LENS SOLUTION
U
Cleared 510(K)
K
86
1642
LENSKEEPER CONTACT LENS CARRYING CASE
U
Cleared 510(K)
K
86
0677
EASY EYES TM LENS CARRYING CASE
U
Cleared 510(K)
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
K
85
4968
BAUSCH & LOMB LENS CARRYING CASE
U
Cleared 510(K)
K
85
3808
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
U
Cleared 510(K)
K
85
3809
DAILY HARD CONTACT LENS CLEANER
U
Cleared 510(K)
K
85
4442
UVASORB-400
U
Cleared 510(K)
K
85
3811
HARD CONTACT LENS SOAKING SOLUTION
U
Cleared 510(K)
K
85
3810
WETTING SOLUTION FOR HARD CONTACT LENSES
U
Cleared 510(K)
K
85
3807
ALL-IN-ONE HARD CONTACT LENS SOLUTION
U
Cleared 510(K)
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
K
85
3728
KESTREL CONTACT LENS STORAGE CASE(NORYL)
U
Cleared 510(K)
K
85
3729
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
85
3870
EASY EYES TM LENS CARRYING CASE
U
Cleared 510(K)
P
82
0061
PARAPERM O2 CONTACT LENS CLEAR & BLUE
U
PMA Approval
K
85
3445
IN A WINK LUBRICATING & REWETTING DROPS
U
Cleared 510(K)
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
K
85
0909
RHODA-LUX LENS BLANKS
U
Cleared 510(K)
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
K
85
2384
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
U
Cleared 510(K)
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
K
85
1887
ON TARGET
U
Cleared 510(K)
K
85
1497
MARLIN CONTACT LENS CASE
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
84
0004
B&L (SYNERGICON A) SYNERCON(TM) CONTACT LENS
U
PMA Approval
K
85
0046
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE
U
Cleared 510(K)
P
82
0065
AQUAFLEX(R) HGP(TM) RIGID GAS PERMEABLE LENSES
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
K
84
1881
EASY EYES TM LENS CARRYING CASE
U
Cleared 510(K)
K
84
3342
LENSKEEPER LENS CARRYING CASE
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
K
83
3903
BENZETHONIUM CHLORIDE
U
Cleared 510(K)
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0063
PARAPERM O2 CONTACT LENS
U
PMA Approval
P
82
0065
BOSTON LENS(R) LENS - CLEAR
U
PMA Approval
N
18
032
CABCURVE (POROFOCAN B)
U
PMA Approval
K
83
1973
HARD CONTACT LENS CASE
U
Cleared 510(K)
K
83
2706
SENSITIVE EYES
U
Cleared 510(K)
K
83
2810
HARD CONTACT LENS CLEANER
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
83
0740
CLERZ LUBRICATING & REWETTING EYE DROPS
U
Cleared 510(K)
N
18
032
CABCURVE (POROFOCAN B)
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
82
3528
GLISLENS
U
Cleared 510(K)
K
82
2315
GFB-B CONTACT LENS BLANKS
U
Cleared 510(K)
K
82
2706
PRE-SERT
U
Cleared 510(K)
K
82
2707
CLEAN-N-SOAK
U
Cleared 510(K)
K
82
2495
LE CASE HARD CONTACT LENS STORAGE CASE
U
Cleared 510(K)
N
18
114
RX-56 POROFOCON A CONTACT LENS
U
PMA Approval
K
82
1866
OXY-PMMA
U
Cleared 510(K)
K
82
2105
LENS EASY ON
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
N
18
114
RX-56 SEMI-RIGID GAS PERMEABLE CONTACT LENS
U
PMA Approval
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
82
1051
LIQUIFILM WETTING SOLUTION
U
Cleared 510(K)
K
82
1052
SOAKARE
U
Cleared 510(K)
K
82
1054
TOTAL
U
Cleared 510(K)
K
82
1055
BLINK-N-CLEAN
U
Cleared 510(K)
K
82
0815
OPTACRY/95 BLUE CONTACT LENS BLANKS
U
Cleared 510(K)
K
82
0817
OPTACRY/95 GRAY CONTACT LENS BLANKS
U
Cleared 510(K)
K
82
0816
OPTACRY/ 95 GREEN CONTACT LENS BLANKS
U
Cleared 510(K)
K
82
0325
STERICIDAL
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
82
0818
CONCENTRATED CLEANER FOR HARD CONTACTS
U
Cleared 510(K)
K
82
0511
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
U
Cleared 510(K)
N
18
032
GP-II(TM) (POROFOCON B) CONTACT LENS
U
PMA Approval
N
18
032
CABCURVE CONTACT LENS (POROFOCON B)
U
PMA Approval
N
18
032
CABCURVE (POROFOCAN B)
U
PMA Approval
K
81
3528
LENS-PAC
U
Cleared 510(K)
K
81
1010
CONTACT LENS MATERL
U
Cleared 510(K)
K
81
2433
LENSINE EXTRA STRENGTH CLEANER
U
Cleared 510(K)
K
81
2172
CONTACT LENS CLEANER
U
Cleared 510(K)
K
81
2135
BARNES-HIND WEEKLY CLEANER
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
81
0130
OPTOCRYL CONTACT LENS BLANKS
U
Cleared 510(K)
N
18
114
RX-56 POROFOCON A CONTACT LENS
U
PMA Approval
N
18
114
RX-56 POROFOCON A CONTACT LENS
U
PMA Approval
N
18
120
POLYCON HARD CONTACT LENSE
U
PMA Approval
K
80
2593
KERATOPLASTY SUTURING LENS
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
N
18
032
CABCURVE CONTACT LENS (POROFOCOM B)
U
PMA Approval
K
80
0582
BARNES-HOND HARD CONTACT LENS STOR. CASE
U
Cleared 510(K)
K
80
0192
DURALITE LENS
U
Cleared 510(K)
K
79
1523
VISALENS ALL PURPOSE SOLUTION FOR LENS
U
Cleared 510(K)
K
79
2224
CONTACT LENSES MADE OF POLYMETHYLMETHACR
U
Cleared 510(K)
K
79
1524
VISALENS CONCENTRATED CLEANER CONT LENS
U
Cleared 510(K)
N
18
120
POLYCON CONTACT LENS
U
PMA Approval
K
78
1007
AUTO-CON
U
Cleared 510(K)
K
78
0823
CONTACT LENS CLEANSER
U
Cleared 510(K)
K
77
0582
LENS, CONTACT, HARD
U
Cleared 510(K)
K
76
0046
CASE, CONTACT LENS, PLASTIC
U
Cleared 510(K)
K
76
0213
LENSES, CONTACT, POLYMETHYL METHACRYLATE
U
Cleared 510(K)
K
76
0204
BUTTONS, PMMA (FOR CONTACT LENSES)
U
Cleared 510(K)
K
76
0126
LENS, HARD CONTACT
U
Cleared 510(K)
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
LQB
Medical Computers And Software For Ophthalmic Use
3
Product Code
LQE
Implant, Corneal, Refractive
3
Product Code
LXQ
Cup, Eye
U
Product Code
LYX
Media, Corneal Storage
U
Product Code
LZQ
Tissue Adhesive For Ophthalmic Use
3
Product Code
LZR
Ultrasound, Cyclodestructive
3
Product Code
LZS
Excimer Laser System
3
Product Code
LZU
Plug, Punctum
U
Product Code
MRJ
Ring, Endocapsular
3
Product Code
MSI
Solution, Cleaning / Lubricating, Artificial Eye
3
Product Code
MTA
Lens, Intraocular, Phakic
3
Product Code
MUR
Graft, Sclera, Reinforcement
3
Product Code
MWD
Electrosurgical, Radio Frequency, Refractive Correction
3
Product Code
NBF
Prosthesis, Retinal
F
Product Code
NCJ
Telescope, Implantable, Miniature
3
Product Code
ODK
Refractive Corneal Implant
F
Product Code
OKS
Lacrimal Stents And Intubation Sets
U
Product Code
OTL
Femtosecond Laser System For Refractive Correction
3
Product Code
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
N
Product Code
PFZ
Ophthalmic Sealant
3
Product Code
QBT
Artificial Iris
3
Product Code
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
2
Product Code
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
Product Code
QQJ
Applicator, Negative Pressure, External, Ocular
2
Product Code
SDE
Light Based Device For Dry Age-Related Macular Degeneration
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
OP
/
OP-misc
/
HPX
/
K781007
View Source
AUTO-CON
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781007
510(k) Type
Traditional
Applicant
BARNES-HIND, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/1978
Days to Decision
11 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
K
95
5777
PMMA CLASIC
K
94
0106
KERATOPLASTY SUTURING LENS
K
91
3081
MULTI-VIEW BIFOCALS
K
89
7021
MARTIN-HENSLEY SEGMENT LENS
K
89
5411
OPTIKEM PMMA CONTACT LENS
K
87
4591
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
K
86
5111
CHARTER HARD CONTACT LENS CLEANING SOLUTION
K
86
4343
BL1 (HARD CONTACT LENS)
K
86
3974
CHARTER LABORATORIES INC. LENS LUBRICANT
K
86
2952
CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES
P
82
0065
BOSTON LENS II & IV
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
P
82
0065
BOSTON LENS II & IV
P
82
0065
BOSTON LENS II & IV
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
P
82
0065
BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION
P
82
0063
PARAPERM O2 (PASIFOCON A) BROWN ,GRAY TINT
P
82
0065
BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION
P
82
0063
PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
N
18
120
POLYCON CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
89
0020
FLUOROCON TM-60
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0061
PARAPERM O2 CONTACT LENS CLEAR & BLUE
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
N
18
120
POLYCON (SILAFOCON A) CONTACT LENSES
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0065
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS
P
82
0063
PARAPERM O2 (PASIFOCON A) CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
N
18
120
POLYCON CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
N
18
120
POLYCON CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
N
18
120
POLYCON CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
87
0009
3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A)
N
18
120
POLYCON CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
N
18
120
POLYCON CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
N
18
120
POLYCON CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
85
0068
SILSOFT (ELASTOFILCON A) CONTACT LENSES
P
83
0050
B&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
85
0008
THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
K
86
2811
AQUALUX LENS CASE
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
K
86
1643
STYLEKEEPER CONTACT LENS CARRYING CASE
K
86
1712
WETTING & SOAKING HARD CONTACT LENS SOLUTION
K
86
1642
LENSKEEPER CONTACT LENS CARRYING CASE
K
86
0677
EASY EYES TM LENS CARRYING CASE
P
84
0004
SATURN II(TM) (SYNERGICON A) CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
K
85
4968
BAUSCH & LOMB LENS CARRYING CASE
K
85
3808
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
K
85
3809
DAILY HARD CONTACT LENS CLEANER
K
85
4442
UVASORB-400
K
85
3811
HARD CONTACT LENS SOAKING SOLUTION
K
85
3810
WETTING SOLUTION FOR HARD CONTACT LENSES
K
85
3807
ALL-IN-ONE HARD CONTACT LENS SOLUTION
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
K
85
3728
KESTREL CONTACT LENS STORAGE CASE(NORYL)
K
85
3729
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)
N
18
120
POLYCON CONTACT LENS
K
85
3870
EASY EYES TM LENS CARRYING CASE
P
82
0061
PARAPERM O2 CONTACT LENS CLEAR & BLUE
K
85
3445
IN A WINK LUBRICATING & REWETTING DROPS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
K
85
0909
RHODA-LUX LENS BLANKS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
K
85
2384
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
K
85
1887
ON TARGET
K
85
1497
MARLIN CONTACT LENS CASE
N
18
120
POLYCON CONTACT LENS
P
83
0070
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
N
18
120
POLYCON CONTACT LENS
P
84
0004
B&L (SYNERGICON A) SYNERCON(TM) CONTACT LENS
K
85
0046
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE
P
82
0065
AQUAFLEX(R) HGP(TM) RIGID GAS PERMEABLE LENSES
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
K
84
1881
EASY EYES TM LENS CARRYING CASE
K
84
3342
LENSKEEPER LENS CARRYING CASE
N
18
120
POLYCON CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0065
BOSTON LENS(R) LENS - CLEAR
P
82
0063
PARAPERM O2 CONTACT LENS
K
83
3903
BENZETHONIUM CHLORIDE
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0063
PARAPERM O2 CONTACT LENS
P
82
0065
BOSTON LENS(R) LENS - CLEAR
N
18
032
CABCURVE (POROFOCAN B)
K
83
1973
HARD CONTACT LENS CASE
K
83
2706
SENSITIVE EYES
K
83
2810
HARD CONTACT LENS CLEANER
N
18
120
POLYCON CONTACT LENS
K
83
0740
CLERZ LUBRICATING & REWETTING EYE DROPS
N
18
032
CABCURVE (POROFOCAN B)
N
18
120
POLYCON CONTACT LENS
K
82
3528
GLISLENS
K
82
2315
GFB-B CONTACT LENS BLANKS
K
82
2706
PRE-SERT
K
82
2707
CLEAN-N-SOAK
K
82
2495
LE CASE HARD CONTACT LENS STORAGE CASE
N
18
114
RX-56 POROFOCON A CONTACT LENS
K
82
1866
OXY-PMMA
K
82
2105
LENS EASY ON
N
18
120
POLYCON CONTACT LENS
N
18
120
POLYCON CONTACT LENS
N
18
114
RX-56 SEMI-RIGID GAS PERMEABLE CONTACT LENS
N
18
120
POLYCON CONTACT LENS
K
82
1051
LIQUIFILM WETTING SOLUTION
K
82
1052
SOAKARE
K
82
1054
TOTAL
K
82
1055
BLINK-N-CLEAN
K
82
0815
OPTACRY/95 BLUE CONTACT LENS BLANKS
K
82
0817
OPTACRY/95 GRAY CONTACT LENS BLANKS
K
82
0816
OPTACRY/ 95 GREEN CONTACT LENS BLANKS
K
82
0325
STERICIDAL
N
18
120
POLYCON CONTACT LENS
K
82
0818
CONCENTRATED CLEANER FOR HARD CONTACTS
K
82
0511
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
N
18
032
GP-II(TM) (POROFOCON B) CONTACT LENS
N
18
032
CABCURVE CONTACT LENS (POROFOCON B)
N
18
032
CABCURVE (POROFOCAN B)
K
81
3528
LENS-PAC
K
81
1010
CONTACT LENS MATERL
K
81
2433
LENSINE EXTRA STRENGTH CLEANER
K
81
2172
CONTACT LENS CLEANER
K
81
2135
BARNES-HIND WEEKLY CLEANER
N
18
120
POLYCON CONTACT LENS
K
81
0130
OPTOCRYL CONTACT LENS BLANKS
N
18
114
RX-56 POROFOCON A CONTACT LENS
N
18
114
RX-56 POROFOCON A CONTACT LENS
N
18
120
POLYCON HARD CONTACT LENSE
K
80
2593
KERATOPLASTY SUTURING LENS
N
18
120
POLYCON CONTACT LENS
N
18
032
CABCURVE CONTACT LENS (POROFOCOM B)
K
80
0582
BARNES-HOND HARD CONTACT LENS STOR. CASE
K
80
0192
DURALITE LENS
K
79
1523
VISALENS ALL PURPOSE SOLUTION FOR LENS
K
79
2224
CONTACT LENSES MADE OF POLYMETHYLMETHACR
K
79
1524
VISALENS CONCENTRATED CLEANER CONT LENS
N
18
120
POLYCON CONTACT LENS
K
78
1007
AUTO-CON
K
78
0823
CONTACT LENS CLEANSER
K
77
0582
LENS, CONTACT, HARD
K
76
0046
CASE, CONTACT LENS, PLASTIC
K
76
0213
LENSES, CONTACT, POLYMETHYL METHACRYLATE
K
76
0204
BUTTONS, PMMA (FOR CONTACT LENSES)
K
76
0126
LENS, HARD CONTACT
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
HPX
/
K781007
View Source
AUTO-CON
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781007
510(k) Type
Traditional
Applicant
BARNES-HIND, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/1978
Days to Decision
11 days