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510(k) Data Aggregation
K Number
K200416Device Name
Boston One Step Liquid Enzymatic Cleaner
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2020-09-23
(216 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Device Description
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
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K Number
K201069Device Name
VibrantVue Scleral Saline
Manufacturer
Dry Eye Innovations, LLC
Date Cleared
2020-07-31
(100 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
Device Description
The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.
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K Number
K182984Device Name
MaxiTears Contacts PF
Manufacturer
Omnivision AG
Date Cleared
2019-07-24
(268 days)
Product Code
MRC, LPN
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
Device Description
The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.
The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.
OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:
- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
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K Number
K181566Device Name
Nutrifill
Manufacturer
Contamac Ltd.
Date Cleared
2018-10-22
(130 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.
Device Description
The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.
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K Number
K181627Device Name
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2018-08-10
(51 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate rigid gas permeable contact lenses.
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Device Description
Bausch + Lomb Boston Simplus Multi-Action Solution is a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalkylphosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%).
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
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K Number
K180319Device Name
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
Manufacturer
Bausch and Lomb Incorporated
Date Cleared
2018-03-27
(50 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Device Description
Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.
Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).
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K Number
K173089Device Name
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2017-11-27
(59 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Boston Original Cleaner is indicated for use to clean silicone acrylate and fluoro silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston Original Conditioning Solutions is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) of fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Device Description
Boston Original Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate and silica gel as cleaning agents, titanium dioxide and fragrance.
Boston Original Conditioning Solutions is a sterile, aqueous buffered, solution containing a cellulosic viscosifier, cationic cellulose derivative polymer and polyvinyl alcohol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.006%) and edetate disodium (EDTA) (0.05%).
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K Number
K173136Device Name
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Manufacturer
Menicon Co., Ltd.
Date Cleared
2017-11-16
(48 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Device Description
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Progent Vial. Menicon Rinse solution is used once the lens soaking cycle is complete. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
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K Number
K130805Device Name
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
Manufacturer
MENICON CO. LTD.
Date Cleared
2013-07-03
(100 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Device Description
Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
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K Number
K122273Device Name
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
Manufacturer
MENICON CO. LTD.
Date Cleared
2013-01-02
(156 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Product Code :
MRC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Device Description
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
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