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by
Innolitics
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Review Panel
Cardiovascular
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
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Hematology
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Immunology
Review Panel
Microbiology
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Neurology
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Obstetrical and Gynecological
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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
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
K
20
0416
Boston One Step Liquid Enzymatic Cleaner
2
Cleared 510(K)
K
20
1069
VibrantVue Scleral Saline
2
Cleared 510(K)
K
18
2984
MaxiTears Contacts PF
2
Cleared 510(K)
K
18
1566
Nutrifill
2
Cleared 510(K)
K
18
1627
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
2
Cleared 510(K)
K
18
0319
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
2
Cleared 510(K)
K
17
3089
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
2
Cleared 510(K)
K
17
3136
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
2
Cleared 510(K)
K
13
0805
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
2
Cleared 510(K)
K
12
2273
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
2
Cleared 510(K)
K
08
2855
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
2
Cleared 510(K)
K
05
2074
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
2
Cleared 510(K)
K
04
0839
COMPLETE BLINK-N-CLEAN LENS DROPS
2
Cleared 510(K)
K
02
4289
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
2
Cleared 510(K)
K
02
3455
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
2
Cleared 510(K)
K
02
0930
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
2
Cleared 510(K)
K
01
3204
AQUIFY LENS COMFORT DROPS
2
Cleared 510(K)
K
01
4162
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
2
Cleared 510(K)
K
01
1456
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
2
Cleared 510(K)
K
00
2140
MENICON PROGENT REMOVER
2
Cleared 510(K)
K
00
0975
LIPIDURE REWETTING DROPS
2
Cleared 510(K)
K
00
1964
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
2
Cleared 510(K)
K
00
1235
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
2
Cleared 510(K)
K
00
1428
OPTIMUM WETTING AND REWETTING DROP
2
Cleared 510(K)
K
00
0607
SOLO-CARE BRAND HARD SOLUTION
2
Cleared 510(K)
K
00
0385
OPTI-FREE EXPRESS LENS DROPS
2
Cleared 510(K)
K
00
0148
RGP MULTI-PURPOSE SOLUTION ID 100136
2
Cleared 510(K)
K
99
4170
HYLASHIELD CL
2
Cleared 510(K)
K
99
3949
SOLO-CARE BRAND HARD SOLUTION
2
Cleared 510(K)
K
98
3836
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
2
Cleared 510(K)
K
98
3291
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
2
Cleared 510(K)
K
97
4466
BOSTON ADVANCE CLEANER
2
Cleared 510(K)
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 9 May 2025 at 11:05 pm
OP
/
subpart-f—therapeutic-devices
/
MRC
/
K000148
View Source
RGP MULTI-PURPOSE SOLUTION ID 100136
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000148
510(k) Type
Traditional
Applicant
ALCON LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2000
Days to Decision
84 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
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
MML
Weights, Eyelid, External
MRC
Products, Contact Lens Care, Rigid Gas Permeable
K
20
0416
Boston One Step Liquid Enzymatic Cleaner
K
20
1069
VibrantVue Scleral Saline
K
18
2984
MaxiTears Contacts PF
K
18
1566
Nutrifill
K
18
1627
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
K
18
0319
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
K
17
3089
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
K
17
3136
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K
13
0805
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K
12
2273
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K
08
2855
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K
05
2074
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
K
04
0839
COMPLETE BLINK-N-CLEAN LENS DROPS
K
02
4289
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K
02
3455
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K
02
0930
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K
01
3204
AQUIFY LENS COMFORT DROPS
K
01
4162
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K
01
1456
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K
00
2140
MENICON PROGENT REMOVER
K
00
0975
LIPIDURE REWETTING DROPS
K
00
1964
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K
00
1235
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
K
00
1428
OPTIMUM WETTING AND REWETTING DROP
K
00
0607
SOLO-CARE BRAND HARD SOLUTION
K
00
0385
OPTI-FREE EXPRESS LENS DROPS
K
00
0148
RGP MULTI-PURPOSE SOLUTION ID 100136
K
99
4170
HYLASHIELD CL
K
99
3949
SOLO-CARE BRAND HARD SOLUTION
K
98
3836
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K
98
3291
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K
97
4466
BOSTON ADVANCE CLEANER
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
/
MRC
/
K000148
View Source
RGP MULTI-PURPOSE SOLUTION ID 100136
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K000148
510(k) Type
Traditional
Applicant
ALCON LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2000
Days to Decision
84 days
Submission Type
Summary