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510(k) Data Aggregation

    K Number
    K033799
    Device Name
    CLINICAL LASETTE P-200
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    2003-12-22

    (17 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ablation of skin for collecting capillary blood samples for subsequent analysis. The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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    K Number
    K021946
    Device Name
    CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    2002-09-11

    (90 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
    Device Description
    The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.
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    K Number
    K983673
    Device Name
    LASETTE
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1999-01-15

    (87 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotic's Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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    K Number
    K981746
    Device Name
    CELL ROBOTICS' LASETTE
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1998-12-07

    (203 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
    Ask a Question
    K Number
    K982230
    Device Name
    LASETTE LASER SKIN PERFORATOR
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1998-09-24

    (177 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ablation of skin tissue to establish capillary blood access. The Cell Robotics Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit.
    Device Description
    The Cell Robotics Laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
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    K Number
    K981149
    Device Name
    LASETTE LASER SKIN PERFORATOR
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1998-06-29

    (90 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from all patients (5 years old and above) for subsequent determination of blood glucose concentration and hematocrit.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
    Ask a Question
    K Number
    K973431
    Device Name
    LASETTE
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1997-10-28

    (48 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics Lasette Laser Skin Perforator is intended for use by qualified healthcare professionals for collecting capillary blood samples from adult patients, for subsequent determination of blood glucose concentration and hematocrit using optically based measurement techniques.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in the patient's fingertip comparable to that produced by commonly used stainless steel blood lancets.
    Ask a Question
    K Number
    K965124
    Device Name
    LASETTE
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1997-08-14

    (234 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics Lasette is intended for use for skin perforation and establishing capillary blood access for blood sampling. The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary blood from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.
    Device Description
    The Cell Robotics Lasette laser skin perforator is a portable battery operated laser device. The device produces a single pulse of laser light which ablates a small hole in a patient's fingertip comparable to that produced by commonly used stainless steel blood lancets. The complete Lasette product includes the Lasette. its labeling and manual, and single-use sanitary (non-sterile) plastic iqns shelds. The Lasette uses a small convection-cooled erbium: YAG solid state laser with a maximum output energy of 0.5 J per pulse at a wavelength of 2.94 micrometers and a pulse width of 300 microsconds. This energy is focused on a target spot with a diameter of 300 micrometers.
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    K Number
    K970461
    Device Name
    CELL ROBOTICS ER: YAG SURGICAL LASER
    Manufacturer
    CELL ROBOTICS, INC.
    Date Cleared
    1997-07-11

    (155 days)

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

    CELL ROBOTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell Robotics, Inc. unnamed Er: YAG Surgical laser is indicated for use in small and large joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision / excision), vaporizing and coagulation of soft tissues, including skin, subcutaneous tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
    Device Description
    The Cell Robotics Er:YAG Surgical Laser is an Er:YAG laser producing laser emission at 2940nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the swing arm and the handpiece, which houses the laser.
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