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510(k) Data Aggregation
K Number
K222541Device Name
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2022-12-06
(106 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
Device Description
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.
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K Number
K221263Device Name
Aqua Naina Plus Sterile Saline Solution
Manufacturer
Chemtex USA Inc.
Date Cleared
2022-10-12
(163 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aqua Naina Plus Sterile Saline Solution: The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution 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. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.
Aqua Naina Sterile Saline Solution: The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.
Device Description
Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only.
Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
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K Number
K202932Device Name
ABT12 multi-purpose solution
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2021-05-28
(241 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
Device Description
Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
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K Number
K210051Device Name
OTE MPS 045 Multi-purpose Lens Care Solution
Manufacturer
OTE North America LLC
Date Cleared
2021-05-26
(138 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Device Description
OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.
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K Number
K193441Device Name
Aqua Naina Sterile Saline Solution
Manufacturer
Chemtex USA, Inc.
Date Cleared
2020-05-26
(167 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
Device Description
Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear colorless aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
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K Number
K200747Device Name
PuriLens Plus Preservative Free Saline
Manufacturer
The LifeStyle Company, Inc.
Date Cleared
2020-05-15
(53 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution 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 PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.
The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.
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K Number
K191872Device Name
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
Manufacturer
Menicon Co., Ltd.
Date Cleared
2020-03-02
(234 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.
Device Description
The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together.
The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).
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K Number
K190674Device Name
REFRESH RELIEVA For CONTACTS
Manufacturer
Allergan, Inc
Date Cleared
2019-08-08
(146 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.
Device Description
REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.
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K Number
K191795Device Name
AOCup Lens Case with AODisc
Manufacturer
Alcon Laboratories, Inc.
Date Cleared
2019-07-31
(28 days)
Product Code
LPN, LRX
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
Device Description
The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.
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K Number
K170483Device Name
Bausch + Lomb Sensitive Eyes Plus Saline Solution
Manufacturer
Bausch & Lomb Incorporated
Date Cleared
2017-04-11
(54 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Product Code :
LPN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
Device Description
Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
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