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510(k) Data Aggregation

    K Number
    K041994
    Device Name
    MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2004-10-06

    (75 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.
    Device Description
    The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.
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    K Number
    K041569
    Device Name
    CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2004-06-30

    (20 days)

    Product Code
    GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
    Device Description
    The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a fluency of light ranging between 50-200 mW/cm2. The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and near infrared range with an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and a timer unit to indicate the duration of light treatment.
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    K Number
    K033183
    Device Name
    RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2004-04-15

    (197 days)

    Product Code
    GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReClear™ Phototherapy System ("ReClear™") is intended to provide phototherapeutic light to the body. The ReClear™ is specifically indicated to emit visible blue/violet light for treatment of moderate inflammatory acne vulgaris. It also emits infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
    Device Description
    The ReClear emits in the range of visible blue/violet light (405-420nm) and infrared light (850 nm to 900 nm) with a fluency of light up to 200mW/cm². The system also includes an optical system for controlling spectra and beam parameters of the light source, a mechanical fixture for holding the light source at an adjustable distance and direction in relation to the skin treatment area, and a timer unit to control the duration of the emitted radiation.
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    K Number
    K032383
    Device Name
    MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2003-11-28

    (119 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K030338
    Device Name
    ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2003-02-12

    (12 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The iClear Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and an timer unit to indicate the duration of light treatment.
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    K Number
    K013623
    Device Name
    CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
    Manufacturer
    CURELIGHT LTD
    Date Cleared
    2002-08-16

    (284 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURELIGHT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, an electronic unit to control the duration, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.
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