FDA Browser
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
Miscellaneous
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
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
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
K
24
0095
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
2
Cleared 510(K)
K
23
1123
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
2
Cleared 510(K)
K
17
3538
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
2
Cleared 510(K)
K
17
2925
Contact Lens Case, Model: A-1, B-1
2
Cleared 510(K)
K
17
3365
Bausch + Lomb Boston Scleral Lens Case
2
Cleared 510(K)
K
17
1539
Contact Lens Case
2
Cleared 510(K)
K
17
1163
Contact Lens Case Round Glasses
2
Cleared 510(K)
K
16
2869
Contact Lens Case
2
Cleared 510(K)
K
16
0005
Contact Lens Case (multiple brand name)
2
Cleared 510(K)
K
14
2717
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
2
Cleared 510(K)
K
14
3351
iCase Contact Lens Case
2
Cleared 510(K)
K
14
0488
CONTACT LENS CASE
2
Cleared 510(K)
K
13
1783
POLAROID CONTACTSPOD
2
Cleared 510(K)
K
13
0930
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
2
Cleared 510(K)
K
13
1875
MENICON NECT CONTACT LENS CASE
2
Cleared 510(K)
K
13
0753
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
2
Cleared 510(K)
K
12
2700
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
2
Cleared 510(K)
K
13
0285
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
2
Cleared 510(K)
K
12
0904
POLARIS DIAL-A-DATE CONTACT LENS CASE
2
Cleared 510(K)
K
12
0969
AC LENS BRANDED CONTACT LENS CASE
2
Cleared 510(K)
K
12
1030
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
2
Cleared 510(K)
K
11
2832
EYE CARE CURE CONTACT LENS CASE
2
Cleared 510(K)
K
11
1856
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
2
Cleared 510(K)
K
09
3377
POLARIS CONTACT LENS CASE
2
Cleared 510(K)
K
09
0362
IMAG, IPOD, EZ-FIND AND ISLIDE
2
Cleared 510(K)
K
07
1081
CONTACT LENS CASE
2
Cleared 510(K)
K
05
2809
SAUFLON FLAT COLOURED LENS CASE
2
Cleared 510(K)
K
04
1820
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
2
Cleared 510(K)
K
04
2578
I-PROMOTIONS CONTACT LENS CASE
2
Cleared 510(K)
K
04
0914
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
2
Cleared 510(K)
K
03
3656
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
2
Cleared 510(K)
K
03
2309
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
2
Cleared 510(K)
K
03
0987
CONTACT LENS STORAGE CASE
2
Cleared 510(K)
K
02
1248
ICASE
2
Cleared 510(K)
K
01
3232
CYBERCASES BY BAUSCH & LOMB
2
Cleared 510(K)
K
99
1206
BONASSE CONTACT LENS CASE
2
Cleared 510(K)
K
99
3486
PARAGON LENS CARRIER
2
Cleared 510(K)
K
99
3487
PARAGON LENS VIAL
2
Cleared 510(K)
K
97
4635
PARAGON LENS CARE
2
Cleared 510(K)
K
97
4281
ALCON CONTACT LENS CASE
2
Cleared 510(K)
K
97
1618
ALCON CONTACT LENS CASE
2
Cleared 510(K)
K
96
2512
BOSTON CONTACT LENS CASE
2
Cleared 510(K)
K
95
0869
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE
2
Cleared 510(K)
K
95
1552
BOSTON CONTACT LENS CASE
2
Cleared 510(K)
K
95
1182
RYDER CONTACT LENS CASE MODEL 10670
2
Cleared 510(K)
K
95
1181
RYDER CONTACT LENS CASE
2
Cleared 510(K)
K
95
0878
MENICON SP VIAL
2
Cleared 510(K)
K
95
0530
PRO-TEC-CASE
2
Cleared 510(K)
K
94
5259
DATEMINDER CONTACT LENS CASE
2
Cleared 510(K)
K
94
3921
RYDER CONTACT LENS CASE
2
Cleared 510(K)
K
94
3183
CIBA VISION(R) CONTACT LENS CASE
2
Cleared 510(K)
K
93
1620
OPTI-FREE CONTACT LENS CASE
2
Cleared 510(K)
K
92
3458
CONTACT LENS CASE
2
Cleared 510(K)
K
92
0064
OPTI-LENS CONTACT LENS CASE
2
Cleared 510(K)
K
91
5082
OPTI-LENS(TM) CONTACT LENS CASE
2
Cleared 510(K)
K
90
1748
KESTREL LENS CASE (208-12NT POLYSTYRENE)
2
Cleared 510(K)
K
90
0777
ITEM #273 CONTACT LENS CASES
2
Cleared 510(K)
K
90
0778
ITEM #272 MAGNIF-EYES CONTACT LENS CASE
2
Cleared 510(K)
K
89
7084
CONFEES(R)+ CONTACT LENS HOLDER
2
Cleared 510(K)
K
89
7085
COMFEES(R) + CON-PAK(TM) LENS CASE
2
Cleared 510(K)
K
90
0054
KESTREL LENS CASE 1543-893S/P-1700-2611
2
Cleared 510(K)
K
90
0053
KESTREL LENS CASE 731H-893S/P-1700-2611
2
Cleared 510(K)
K
89
5167
THE OPTIC BOX CONTACT LENS CASE
2
Cleared 510(K)
K
89
6685
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
2
Cleared 510(K)
K
89
0533
ITEM #352/#CS352* CONTACT LENS CASES
2
Cleared 510(K)
K
88
2384
DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
2
Cleared 510(K)
K
88
4251
ALLERGAN LENS CASE
2
Cleared 510(K)
K
87
3822
MOBAY (BAYER) MERLON M-40 (H)F 1112
2
Cleared 510(K)
K
87
3820
MOBAY (BAYER) MAKROLON 2658 1112
2
Cleared 510(K)
K
87
3824
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
2
Cleared 510(K)
K
87
3823
MOBAY (BAYER) MAKROLON 2658 3291
2
Cleared 510(K)
K
87
3821
GE NORYL 731-80089S
2
Cleared 510(K)
K
87
3825
GE LEXAN 144R 112
2
Cleared 510(K)
K
87
5197
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
2
Cleared 510(K)
K
87
4657
RIGID-LENS CASE
2
Cleared 510(K)
K
87
1741
EASY EYES TM LENS CARRYING CASE
2
Cleared 510(K)
K
87
0164
SUMMIT OPTICS SOFT CONTACT LENS CASE
2
Cleared 510(K)
K
85
3727
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)
2
Cleared 510(K)
K
84
0692
CONTACT LENS CASE FOR SOFT LENSES
2
Cleared 510(K)
K
84
0691
CONTACT LENS CASE FOR RIGID GAS PERMA
2
Cleared 510(K)
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
QIU
Intense Pulsed Light Device For Managing Dry Eye
2
Product Code
QKV
Electromechanical Tear Stimulator
2
Product Code
QMM
Hydrophilic Re-Coating Solution
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 May 2025 at 11:05 pm
OP
/
subpart-f—therapeutic-devices
/
LRX
/
K130753
View Source
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130753
510(k) Type
Traditional
Applicant
WATCHDOG GROUP, LC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2013
Days to Decision
86 days
Submission Type
Summary
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
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
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)
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
K
24
0095
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K
23
1123
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
K
17
3538
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K
17
2925
Contact Lens Case, Model: A-1, B-1
K
17
3365
Bausch + Lomb Boston Scleral Lens Case
K
17
1539
Contact Lens Case
K
17
1163
Contact Lens Case Round Glasses
K
16
2869
Contact Lens Case
K
16
0005
Contact Lens Case (multiple brand name)
K
14
2717
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
K
14
3351
iCase Contact Lens Case
K
14
0488
CONTACT LENS CASE
K
13
1783
POLAROID CONTACTSPOD
K
13
0930
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K
13
1875
MENICON NECT CONTACT LENS CASE
K
13
0753
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
K
12
2700
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K
13
0285
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K
12
0904
POLARIS DIAL-A-DATE CONTACT LENS CASE
K
12
0969
AC LENS BRANDED CONTACT LENS CASE
K
12
1030
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
K
11
2832
EYE CARE CURE CONTACT LENS CASE
K
11
1856
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K
09
3377
POLARIS CONTACT LENS CASE
K
09
0362
IMAG, IPOD, EZ-FIND AND ISLIDE
K
07
1081
CONTACT LENS CASE
K
05
2809
SAUFLON FLAT COLOURED LENS CASE
K
04
1820
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K
04
2578
I-PROMOTIONS CONTACT LENS CASE
K
04
0914
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K
03
3656
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K
03
2309
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
K
03
0987
CONTACT LENS STORAGE CASE
K
02
1248
ICASE
K
01
3232
CYBERCASES BY BAUSCH & LOMB
K
99
1206
BONASSE CONTACT LENS CASE
K
99
3486
PARAGON LENS CARRIER
K
99
3487
PARAGON LENS VIAL
K
97
4635
PARAGON LENS CARE
K
97
4281
ALCON CONTACT LENS CASE
K
97
1618
ALCON CONTACT LENS CASE
K
96
2512
BOSTON CONTACT LENS CASE
K
95
0869
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE
K
95
1552
BOSTON CONTACT LENS CASE
K
95
1182
RYDER CONTACT LENS CASE MODEL 10670
K
95
1181
RYDER CONTACT LENS CASE
K
95
0878
MENICON SP VIAL
K
95
0530
PRO-TEC-CASE
K
94
5259
DATEMINDER CONTACT LENS CASE
K
94
3921
RYDER CONTACT LENS CASE
K
94
3183
CIBA VISION(R) CONTACT LENS CASE
K
93
1620
OPTI-FREE CONTACT LENS CASE
K
92
3458
CONTACT LENS CASE
K
92
0064
OPTI-LENS CONTACT LENS CASE
K
91
5082
OPTI-LENS(TM) CONTACT LENS CASE
K
90
1748
KESTREL LENS CASE (208-12NT POLYSTYRENE)
K
90
0777
ITEM #273 CONTACT LENS CASES
K
90
0778
ITEM #272 MAGNIF-EYES CONTACT LENS CASE
K
89
7084
CONFEES(R)+ CONTACT LENS HOLDER
K
89
7085
COMFEES(R) + CON-PAK(TM) LENS CASE
K
90
0054
KESTREL LENS CASE 1543-893S/P-1700-2611
K
90
0053
KESTREL LENS CASE 731H-893S/P-1700-2611
K
89
5167
THE OPTIC BOX CONTACT LENS CASE
K
89
6685
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K
89
0533
ITEM #352/#CS352* CONTACT LENS CASES
K
88
2384
DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
K
88
4251
ALLERGAN LENS CASE
K
87
3822
MOBAY (BAYER) MERLON M-40 (H)F 1112
K
87
3820
MOBAY (BAYER) MAKROLON 2658 1112
K
87
3824
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
K
87
3823
MOBAY (BAYER) MAKROLON 2658 3291
K
87
3821
GE NORYL 731-80089S
K
87
3825
GE LEXAN 144R 112
K
87
5197
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
K
87
4657
RIGID-LENS CASE
K
87
1741
EASY EYES TM LENS CARRYING CASE
K
87
0164
SUMMIT OPTICS SOFT CONTACT LENS CASE
K
85
3727
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)
K
84
0692
CONTACT LENS CASE FOR SOFT LENSES
K
84
0691
CONTACT LENS CASE FOR RIGID GAS PERMA
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
QIU
Intense Pulsed Light Device For Managing Dry Eye
QKV
Electromechanical Tear Stimulator
QMM
Hydrophilic Re-Coating Solution
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
subpart-f—therapeutic-devices
/
LRX
/
K130753
View Source
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130753
510(k) Type
Traditional
Applicant
WATCHDOG GROUP, LC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2013
Days to Decision
86 days
Submission Type
Summary