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510(k) Data Aggregation

    K Number
    K211361
    Device Name
    3N Contact Lenses Adjunct Cleaner
    Manufacturer
    Suzhou 3N Biological Technology Co., Ltd
    Date Cleared
    2022-01-13

    (255 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.
    Device Description
    The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions. The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses. The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber. The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.
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    K Number
    K210300
    Device Name
    VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
    Manufacturer
    VueSonic, LLC
    Date Cleared
    2021-04-01

    (57 days)

    Product Code
    LYL, MRC
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology. The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
    Device Description
    The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion. The proposed device consists of two versions: - For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and - For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
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    K Number
    K083757
    Device Name
    BPZ02 MULTIPURPOSE SOLUTION
    Manufacturer
    BAUSCH & LOMB, INC.
    Date Cleared
    2009-11-18

    (336 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of 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 BPZ02 MultiPurpose Solution is a sterile, isotonic solution that contains hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium and sodium chloride; and preserved with a dual disinfection system. 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
    K021699
    Device Name
    AUTOLENS CLEANING AND DISINFECTING UNIT
    Manufacturer
    AUTOLENS INC.
    Date Cleared
    2002-12-16

    (208 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTOLENS ® Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENS® Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENS® Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENS® Multipurpose Solution. AUTOLENS® Multipurpose Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) and PMMA contact lenses as recommended by your eye care practitioner.
    Device Description
    The device is a holder, cleaning and disinfection system for contact lenses. It consists of a contact lens holder, bottle, cap and base. A separate battery operated tumbler device is integral to the system. It is designed to slowly tumble the bottle assembly including contact lens solution to effect cleaning of contact lenses. The lens holder is a single piece molded plastic device including hinged snap closure covers to contain each contact lens separately. An easily identifiable, raised letter "R" and "L" is included adjacent each closure receptacle to allow clear identification for right and left contact lenses placed within the lens holder. The lens holder contains openings to sufficiently allow the free flow of solution to circulate on all surfaces of the contact lens during the cleaning process. The bottle is made of molded plastic and is of oval shape to facilitate the flow of solution over the lens holder and lenses during operation. The bottle is of sufficient size to contain the lens holder and 8 ml. of contact lens solution to cover the contact lenses at all times during operation and storage. The bottle is designed to hold the contact lens holder securely to ensure its rotation as the bottle spins during operation. The bottle is designed with a fluid-tight, screw closure cap. The lens holder, bottle, cap and base are made of polypropylene resin plastic. The tumbler device is a battery powered unit operating at 1.5 volts utilizing three "AA" batteries. A plastic housing is molded to contain a small electrical motor, tumbler drive, on/off switch, batteries and a battery door to easily replace batteries. A cradle is molded within the shape of the housing to contain the assembled lens holder bottle. The drive shaft is connected to the motor inside the base housing. When the device is turned on at the switch, the battery operated electrical motor turns the extended drive shaft. The bottle assembly resting upon the drive shaft turns in unison. The mechanical action of the bottle assembly on the drive shaft provides for a rotation of approximately 10 RPM.
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    K Number
    K022687
    Device Name
    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2002-11-19

    (98 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.
    Device Description
    The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.
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    K Number
    K020802
    Device Name
    RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Date Cleared
    2002-05-31

    (80 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
    Device Description
    Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE® (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED® (polvaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
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    K Number
    K994021
    Device Name
    CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
    Manufacturer
    STRIETER CLINICAL RESEARCH LABORATORIES, INC.
    Date Cleared
    2000-02-22

    (88 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.
    Device Description
    Not Found
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    K Number
    K991965
    Device Name
    PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
    Manufacturer
    PURILENS, INC.
    Date Cleared
    1999-10-01

    (113 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Purilense System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.
    Device Description
    The device is a cleaning and disinfection unit for contact lenses. It consists of the Purilens Unit and Purilens Solution. The Purilens Unit is compact, with an upper housing containing a germicidal UV light, and a lower housing which contains a removable, clear cleaning chamber with a lens holder for the contact lenses. A mechanism in the lower portion of the cleaning chamber creates the cleaning turbulence activity. Within the lower housing unit is an electronic control unit which operates the UV light and turbulence vibrating mechanism. The lower unit contains an internal automatic timing device which shuts the unit after its 15 minute cycle. The lens holder consists of a removable basket which houses the contact lenses in separate chambers and is suspended within the cleaning chamber in the lower housing. The removable basket assembly is shielded from the UV light. The cleaning chamber contains an unpreserved saline medium as a storage solution for the contact lenses. The Purilens Solution is a preservative free saline solution which is used to fill the cleaning chamber. The turbulence mechanism is a magnetic pedal suspended on the end of a flexible spring located in the bottom of the cleaning chamber. When activated by the electronic connection, the pedal osillates in a subsonic range of 50 - 120 cycles per second creating a whirlpool effect that swirls the Purilens Solution surrounding the lens baskets and removes debris and microorganisms from the lenses during the 15 minute cycle. UV radiation energy from the upper housing disinfects loosened microorganisms in the solution. Disinfection is accomplished without heating, preservatives, or chemicals. The unit cannot function unless the electrical interlock is complete between the upper and lower housings. An electrical transformer is located on the power cord. The transformer converts house current of 110 VAC to 14 VAC for the purpose of operating the device.
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    K Number
    K982115
    Device Name
    LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
    Manufacturer
    RIM-WIDE COMPANIES, INC.
    Date Cleared
    1999-01-13

    (211 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions. Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allergan Soft Mate Consept-2 Neutralizing and Rinsing Solution, or Spray. The LENSERVER Automatic is indicated for cleaning rigid gas permeable lenses in conjunction with approved solutions such as Allergan Gas Permeable Daily Cleaner and Allergan ComfortCare Gas Permeable Wetting and Soaking Solution.
    Device Description
    The LENSERVER Automatic Contact Lens Cleaning Accessory is an electro-mechanical contact lens cleaning device designed to be used in conjunction with approved contact lens cleaning solutions. The cleaning components of the LENSERVER Automatic consist of a motorized cleaninq unit and a partitioned fluid reservoir functioning as the cleaning beaker. The motorized unit is manufactured from a polymer and houses the battery compartment. motor and control circuits. The fluid reservoir or lens receptacle/cleaning beaker is partitioned and injection molded from medical grade polymer. Fill marks are engraved on the outer wall of the beaker indicating a fluid volume sufficient to completely submerge contact lenses. Each contact lens would be placed into the appropriate compartment. designated "L' or 'R'. The base of the fluid reservoir or cleaning beaker fits snugly onto a vibrating platform on the motorized cleaning unit. When placed on the vibrating platform and the power button is actuated, the cleaning beaker vibrates, and after a predetermined period the timing mechanism halts rotation of the motor.
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    K Number
    K974724
    Device Name
    SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
    Manufacturer
    LENS COMFORT, INC.
    Date Cleared
    1998-03-02

    (74 days)

    Product Code
    LYL
    Regulation Number
    886.5928
    Why did this record match?
    Product Code :

    LYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses. The New Comfort Contact lens Care Accessory is indicatod as aid for cleaning as an accessory for soft hydrophilic lenses and gas pormoablo lonsos whon usod with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfoction Systom which is comprisod of the Allergan® Soft Mato® Consept®-1 Cleaning and Disinfecting solution and Allergen® Soft Mate® Consept - 2 Neutralizing and Rinsing Solution or Spray. The New Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Allergan® Gas Permeable Daily Cleaner and Allergan® ComfortCare GP Wetting and Soaking Solution. The New Comfort Contact Lens Care Accessory may be used for a receptacle for chemical disinfection.
    Device Description
    The New Comfort Ultrasonic Contact Lens Care Accessory uses a piezo-electric crystal to generate a wave form, in a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of temperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The New Comfort device uses standard power (110 v/120 v). There is a four (4) foot cord and a UL approved wall transformer. The New Comfort device consists of the housing, lens baskets, a reservoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally marketed predicate devices in the United States. The housing is injection molded of ABS. The baskets and supporting structure are injection molded from ABS. The reservoir is deep drawn stainless steel, is passivated and electropolished. The electronic circuitry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
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