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510(k) Data Aggregation
K Number
K060924Device Name
JSZ MULTIACTION GP CONTACT LENS SOLUTION
Manufacturer
SZABOCSIK AND ASSOCIATES
Date Cleared
2006-06-28
(85 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
SZABOCSIK AND ASSOCIATES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JSZ MultiAction GP Contact Lens Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfection, storage and conditioning of rigid gas permeable contact lenses, including fluorosilicone acrylate and silicone acrylate lenses, as recommended by your eye care practitioner.
JSZ Wetting/Rewetting Eyedrop is indicated to rewet soft (hydrophilic) and to cushion and wet rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, before application and during lens wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.
Device Description
Both products are sterile, isotonic solutions that contain poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polydum ide 0.0001%. Contain no chlorhexidine, no thimerosal, nor any other mercury containo products.
The products are packaged in sizes appropriate to their intended uses: JSZ MultiAction GP Contact Lens Solution in 2oz (60ml) and 4oz (120ml) bottles, JSZ Wetting/Rewetting Eyedrop in 0.5oz (15ml) and 1oz (30ml) bottles.
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K Number
K052074Device Name
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
Manufacturer
SZABOCSIK AND ASSOCIATES
Date Cleared
2005-09-01
(31 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Applicant Name (Manufacturer) :
SZABOCSIK AND ASSOCIATES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.
JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses.
JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.
JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.
Device Description
Cleaning, Disinfecting and Storing Solutions; and Wetting, Lubricating and Rewetting Solutions for Rigid Gas Permeable Contact Lenses.
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K Number
K050517Device Name
JSZ-MULTIPURPOSE SOLUTION
Manufacturer
SZABOCSIK AND ASSOCIATES
Date Cleared
2005-04-13
(43 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
SZABOCSIK AND ASSOCIATES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
Device Description
The JSZ-Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. This product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
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