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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
HJF
Magnifier, Hand-Held, Low-Vision
1
Product Code
HJG
System, Reading, Television, Closed-Circuit
1
Product Code
HJH
Loupe, Binocular, Low Power
1
Product Code
HJX
Reader, Prism, Ophthalmic
1
Product Code
HJY
Reader, Bar, Ophthalmic
1
Product Code
HJZ
Crutch, Ptosis
1
Product Code
HKB
Telescope, Hand-Held, Low-Vision
1
Product Code
HKC
Spectacle Microscope, Low-Vision
1
Product Code
HKK
Telescope, Spectacle, Low-Vision
1
Product Code
HOI
Spectacle, Magnifying
1
Product Code
HOT
Aid, Vision Image Intensification
1
Product Code
HPE
Aid, Vision, Optical, Battery-Powered
1
Product Code
HPF
Aid, Vision, Electronic, Ac-Powered
1
Product Code
HPG
Aid, Vision, Electronic, Battery-Powered
1
Product Code
HPI
Aid, Vision, Optical, Ac-Powered
1
Product Code
HQD
Lens, Contact (Other Material) - Daily
2
Product Code
HQG
Lens, Spectacle, Non-Custom (Prescription)
1
Product Code
K
93
5919
SUNGLASSES
1
Cleared 510(K)
K
92
0795
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
1
Cleared 510(K)
K
90
0091
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
1
Cleared 510(K)
K
88
4360
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
1
Cleared 510(K)
K
88
2814
NEOLENS PRESCRIPTION SPECTACLE LENS
1
Cleared 510(K)
K
88
2308
CR-39 PLASTIC LENSES FOR EYEGLASSES
1
Cleared 510(K)
K
88
1225
OPHTHALMIC SPECTACLE LENS BLANKS
1
Cleared 510(K)
K
87
5063
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
1
Cleared 510(K)
K
87
4681
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
1
Cleared 510(K)
K
87
3245
AR DIACOAT SINGLE VISION LENSES
1
Cleared 510(K)
K
87
2506
MELANITE I
1
Cleared 510(K)
K
87
1961
MULTIPLE SPECTACLE LENS
1
Cleared 510(K)
K
86
5103
KROM-X LENS SYSTEM
1
Cleared 510(K)
K
86
3367
FORMALENS 2000
1
Cleared 510(K)
K
86
2578
TECHNA VISION CASTING RESIN
1
Cleared 510(K)
K
86
1021
GOTTEX SUNGLASSES
1
Cleared 510(K)
K
86
1960
ZIMLITE LENS
1
Cleared 510(K)
K
86
1759
GIRARD SUNGLASSES (NON-PRESCRIPTION)
1
Cleared 510(K)
K
86
1684
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
1
Cleared 510(K)
K
86
1162
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
1
Cleared 510(K)
K
86
0794
WRAPPERS, SUNGLASSES
1
Cleared 510(K)
K
86
0955
SPECTACLES LENS
1
Cleared 510(K)
K
85
4218
THE ULTRA-MATE LENS
1
Cleared 510(K)
K
85
1410
O.M.S. UV-COLOURS
1
Cleared 510(K)
K
85
2403
AURALITE II
1
Cleared 510(K)
K
85
3110
SPECTACLE PRESCRIPTION LENSES
1
Cleared 510(K)
K
85
1163
SUNGLASES
1
Cleared 510(K)
K
85
0905
CR-39 TYPE RESIN
1
Cleared 510(K)
K
84
4778
SUNGLASSES
1
Cleared 510(K)
K
84
2187
MULTIPLE LENS, SPECTACLES, CUSTOM
1
Cleared 510(K)
K
84
2189
MULTIPLE LENS, SPECTACLES CUSTOM
1
Cleared 510(K)
K
84
4321
CUSTOM LITE
1
Cleared 510(K)
K
84
3096
CRISTY/COTE
1
Cleared 510(K)
K
84
1248
SUNGLASSES
1
Cleared 510(K)
K
83
3259
MULTIPLE
1
Cleared 510(K)
K
82
3825
NOSITE UV INTERIM SPECTACLES
1
Cleared 510(K)
K
82
2573
SUNGLASS LENSES
1
Cleared 510(K)
K
82
1398
CORNING CPF 550 LENS
1
Cleared 510(K)
K
81
3130
SUNGLASSES
1
Cleared 510(K)
K
81
2441
DI-CROWN
1
Cleared 510(K)
K
81
2051
PHOTOLITE AOLITE TINTOMATIC LENS
1
Cleared 510(K)
K
81
1554
BARNES-HIND SPECTACLE LENS CLEANER
1
Cleared 510(K)
K
80
2749
BLENDED BIFOCAL
1
Cleared 510(K)
K
80
2651
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
1
Cleared 510(K)
K
80
0521
THE LENS OR OMMI-GARD
1
Cleared 510(K)
K
79
1901
BARNES-HIND WETTING & SOAKING SOLUTION
1
Cleared 510(K)
K
79
1721
ULTRAVUE BLENDED BIFOCAL LENS
1
Cleared 510(K)
K
79
0251
FUL-VUE ASPHERIC CATARACT LENS
1
Cleared 510(K)
K
79
0215
LENS, POLYCORE
1
Cleared 510(K)
K
78
1927
HUMAN II LENS
1
Cleared 510(K)
K
77
2221
LENS, HARD RESIN
1
Cleared 510(K)
K
77
2124
LENSES, EYEGLASS, SAFETY
1
Cleared 510(K)
K
77
2044
TECHSIGHT LENSES WITH ZUMA COATING
1
Cleared 510(K)
K
77
2024
RX LENS SERIES
1
Cleared 510(K)
K
77
0955
MIRACLELENS
1
Cleared 510(K)
K
76
1163
AD7 PLASTIC MULTIFOCAL EYEGLASS LENS
1
Cleared 510(K)
HQY
Sunglasses (Non-Prescription Including Photosensitive)
1
Product Code
HQZ
Frame, Spectacle
1
Product Code
HRC
Sterilizer, Soft-Lens, Thermal, Battery-Powered
2
Product Code
HRD
Sterilizer, Soft-Lens, Thermal, Ac-Powered
2
Product Code
HRL
Unit, Beta, Radiation, Ophthalmic
2
Product Code
KYE
Inserter/Remover Contact Lens
1
Product Code
LPL
Lenses, Soft Contact, Daily Wear
2
Product Code
LPM
Lenses, Soft Contact, Extended Wear
3
Product Code
LPN
Accessories, Soft Lens Products
2
Product Code
LRX
Case, Contact Lens
2
Product Code
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
2
Product Code
MML
Weights, Eyelid, External
2
Product Code
MRC
Products, Contact Lens Care, Rigid Gas Permeable
2
Product Code
MUW
Lens, Contact (Orthokeratology)
2
Product Code
MVN
Lens, Contact, (Disposable)
2
Product Code
MWL
Lens, Contact (Rigid Gas Permeable), Extended Wear
3
Product Code
MZD
System, In-Office Tinting, Contact Lenses
2
Product Code
NAI
Lens, Prescription, Color Deficiency
1
Product Code
NCB
Weights, Eyelid, Implantable
2
Product Code
NCZ
Lens, Contact, For Color Vision Deficiency
2
Product Code
NIC
Lens, Contact, For Reading Discomfort
2
Product Code
NJH
Lens, Spectacle (Prescription), For Reading Discomfort
1
Product Code
NUU
Lens, Contact, Orthokeratology, Overnight
3
Product Code
ORZ
Eyelid Thermal Pulsation System
2
Product Code
PIC
Oral Electronic Vision Aid
2
Product Code
PLX
Tear Duct Occluder
1
Product Code
PQJ
Intranasal Electrostimulation Device
2
Product Code
QBR
Intranasal Electrostimulation Device For Dry Eye Symptoms
2
Product Code
QKV
Electromechanical Tear Stimulator
2
Product Code
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 2 June 2023 at 11:04 pm
OP
/
therapeutic-devices
/
HQG
/
K844778
View Source
SUNGLASSES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844778
510(k) Type
Traditional
Applicant
B & M SPORTING GOODS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/1985
Days to Decision
25 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
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
Therapeutic Devices
HJF
Magnifier, Hand-Held, Low-Vision
HJG
System, Reading, Television, Closed-Circuit
HJH
Loupe, Binocular, Low Power
HJX
Reader, Prism, Ophthalmic
HJY
Reader, Bar, Ophthalmic
HJZ
Crutch, Ptosis
HKB
Telescope, Hand-Held, Low-Vision
HKC
Spectacle Microscope, Low-Vision
HKK
Telescope, Spectacle, Low-Vision
HOI
Spectacle, Magnifying
HOT
Aid, Vision Image Intensification
HPE
Aid, Vision, Optical, Battery-Powered
HPF
Aid, Vision, Electronic, Ac-Powered
HPG
Aid, Vision, Electronic, Battery-Powered
HPI
Aid, Vision, Optical, Ac-Powered
HQD
Lens, Contact (Other Material) - Daily
HQG
Lens, Spectacle, Non-Custom (Prescription)
K
93
5919
SUNGLASSES
K
92
0795
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
K
90
0091
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
K
88
4360
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
K
88
2814
NEOLENS PRESCRIPTION SPECTACLE LENS
K
88
2308
CR-39 PLASTIC LENSES FOR EYEGLASSES
K
88
1225
OPHTHALMIC SPECTACLE LENS BLANKS
K
87
5063
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
K
87
4681
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
K
87
3245
AR DIACOAT SINGLE VISION LENSES
K
87
2506
MELANITE I
K
87
1961
MULTIPLE SPECTACLE LENS
K
86
5103
KROM-X LENS SYSTEM
K
86
3367
FORMALENS 2000
K
86
2578
TECHNA VISION CASTING RESIN
K
86
1021
GOTTEX SUNGLASSES
K
86
1960
ZIMLITE LENS
K
86
1759
GIRARD SUNGLASSES (NON-PRESCRIPTION)
K
86
1684
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
K
86
1162
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
K
86
0794
WRAPPERS, SUNGLASSES
K
86
0955
SPECTACLES LENS
K
85
4218
THE ULTRA-MATE LENS
K
85
1410
O.M.S. UV-COLOURS
K
85
2403
AURALITE II
K
85
3110
SPECTACLE PRESCRIPTION LENSES
K
85
1163
SUNGLASES
K
85
0905
CR-39 TYPE RESIN
K
84
4778
SUNGLASSES
K
84
2187
MULTIPLE LENS, SPECTACLES, CUSTOM
K
84
2189
MULTIPLE LENS, SPECTACLES CUSTOM
K
84
4321
CUSTOM LITE
K
84
3096
CRISTY/COTE
K
84
1248
SUNGLASSES
K
83
3259
MULTIPLE
K
82
3825
NOSITE UV INTERIM SPECTACLES
K
82
2573
SUNGLASS LENSES
K
82
1398
CORNING CPF 550 LENS
K
81
3130
SUNGLASSES
K
81
2441
DI-CROWN
K
81
2051
PHOTOLITE AOLITE TINTOMATIC LENS
K
81
1554
BARNES-HIND SPECTACLE LENS CLEANER
K
80
2749
BLENDED BIFOCAL
K
80
2651
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K
80
0521
THE LENS OR OMMI-GARD
K
79
1901
BARNES-HIND WETTING & SOAKING SOLUTION
K
79
1721
ULTRAVUE BLENDED BIFOCAL LENS
K
79
0251
FUL-VUE ASPHERIC CATARACT LENS
K
79
0215
LENS, POLYCORE
K
78
1927
HUMAN II LENS
K
77
2221
LENS, HARD RESIN
K
77
2124
LENSES, EYEGLASS, SAFETY
K
77
2044
TECHSIGHT LENSES WITH ZUMA COATING
K
77
2024
RX LENS SERIES
K
77
0955
MIRACLELENS
K
76
1163
AD7 PLASTIC MULTIFOCAL EYEGLASS LENS
HQY
Sunglasses (Non-Prescription Including Photosensitive)
HQZ
Frame, Spectacle
HRC
Sterilizer, Soft-Lens, Thermal, Battery-Powered
HRD
Sterilizer, Soft-Lens, Thermal, Ac-Powered
HRL
Unit, Beta, Radiation, Ophthalmic
KYE
Inserter/Remover Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
LPM
Lenses, Soft Contact, Extended Wear
LPN
Accessories, Soft Lens Products
LRX
Case, Contact Lens
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
MML
Weights, Eyelid, External
MRC
Products, Contact Lens Care, Rigid Gas Permeable
MUW
Lens, Contact (Orthokeratology)
MVN
Lens, Contact, (Disposable)
MWL
Lens, Contact (Rigid Gas Permeable), Extended Wear
MZD
System, In-Office Tinting, Contact Lenses
NAI
Lens, Prescription, Color Deficiency
NCB
Weights, Eyelid, Implantable
NCZ
Lens, Contact, For Color Vision Deficiency
NIC
Lens, Contact, For Reading Discomfort
NJH
Lens, Spectacle (Prescription), For Reading Discomfort
NUU
Lens, Contact, Orthokeratology, Overnight
ORZ
Eyelid Thermal Pulsation System
PIC
Oral Electronic Vision Aid
PLX
Tear Duct Occluder
PQJ
Intranasal Electrostimulation Device
QBR
Intranasal Electrostimulation Device For Dry Eye Symptoms
QKV
Electromechanical Tear Stimulator
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
therapeutic-devices
/
HQG
/
K844778
View Source
SUNGLASSES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844778
510(k) Type
Traditional
Applicant
B & M SPORTING GOODS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/1985
Days to Decision
25 days