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510(k) Data Aggregation

    K Number
    K994014
    Device Name
    ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    2000-02-24

    (90 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.
    Device Description
    Not Found
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    K Number
    K991935
    Device Name
    EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    2000-01-27

    (232 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
    Device Description
    EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
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    K Number
    K982119
    Device Name
    DIODE LASER
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1999-02-04

    (233 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
    Device Description
    The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength
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    K Number
    K974536
    Device Name
    PHOTODERM HR SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1998-05-20

    (169 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PhotoDerm® HR is intended for the removal of unwanted hair. The PhotoDerm® HR is used for the removal of unwanted hair.
    Device Description
    PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.
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    K Number
    K980537
    Device Name
    ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1998-04-15

    (63 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
    Device Description
    The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.
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    K Number
    K972872
    Device Name
    DERMA K LASER SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-10-28

    (85 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.
    Device Description
    The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.
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    K Number
    K972028
    Device Name
    DERMASCAN SURGICAL LASER SCANNER
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-10-24

    (144 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.
    Device Description
    DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area
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    K Number
    K963249
    Device Name
    EPILIGHT HAIR REMOVAL SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-07-07

    (322 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair. The EpiLight TM Hair Removal System is used for the removal of unwanted hair
    Device Description
    EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal
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    K Number
    K964253
    Device Name
    DERMA 20 LASER SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1997-04-11

    (169 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Incision, excision, ablation, vaporization and hemostasis of soft tissue
    Device Description
    Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser, operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7 joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per second. The system is composed of the following units: • Laser optical rail assembly • Articulated arm • Power supply and pulse forming network (PFN) • Cooling system • Control electronics system • Power distribution box
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    K Number
    K960772
    Device Name
    PHOTODERM PL.
    Manufacturer
    ESC MEDICAL SYSTEMS LTD.
    Date Cleared
    1996-09-11

    (198 days)

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

    ESC MEDICAL SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos.
    Device Description
    PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.
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