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510(k) Data Aggregation

    K Number
    K111771
    Device Name
    NON-CONTACT TEAR FILM THERMOGRAGH
    Date Cleared
    2011-11-30

    (160 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED INTEGRATED SERVICES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.
    Device Description
    The ocular surface temperature is measured by the thermal sensor of the thermograph system. The subject places his/her chin and forehead to the measuring bracket. Keep both eyes on the camera of the thermograph system. Listen to the voice instruction to close and open his/her eyes for recording the temperature variation of his/her ocular surface.
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    K Number
    K102134
    Device Name
    MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
    Date Cleared
    2010-12-23

    (147 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED INTEGRATED SERVICES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
    Device Description
    The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles. LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_ + laser diode assembly are put on the skin for treatment.
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    K Number
    K082686
    Device Name
    MULTI-CHANNEL LASER THERAPY SYSTEM
    Date Cleared
    2009-05-11

    (238 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED INTEGRATED SERVICES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Multi-Channel Laser Therapy System (Model no.: LA-400) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
    Device Description
    The Multi-Channel Laser Therapy System LA-400 is a noninvasive, conamic casel Therapy System LA-400 is a not deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minored spectrum for the purpos temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where arthritis, for the temporary increase in le l Lacer The (Model no.: LA-400) is interapy System infrared spectrum to provide to emit energy in the infrared spectrum to provide topical heating for the of elevating tissue temporature for the purpose of elevating tissue temperature for the temporary relief of temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied minor muscle and the joint pain and stiffness, for the temporary relia temporary relief of miner in in in in the LA-400 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-400 contains four (4) channels of laser. For each channel of the Multi-Channel Laser Therapy System , LA-400 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup + laser diode assembly are put on the skin for treatment. Note A : Basic operation and treatment of LA-400 is utilizing the laser module mounted in the cup (we call laser module cup) which will be hand-held and put on skin easily.
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