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510(k) Data Aggregation

    K Number
    K153164
    Device Name
    LunulaLaser
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2016-06-03

    (214 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomyosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
    Device Description
    Not Found
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    K Number
    K132940
    Device Name
    ERCHONIA ALLAY
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2014-04-14

    (207 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.
    Device Description
    Erchonia Allay
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    K Number
    K130996
    Device Name
    ERCHONIA EMERGE
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2013-09-16

    (159 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia® XLR8™ laser is indicated for the following three indications: - a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin - b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process - c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
    Device Description
    Not Found
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    K Number
    K130922
    Device Name
    ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2013-05-17

    (44 days)

    Product Code
    OLI, LYG
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ERCHONIA® Verju™ Laser System with Massager is indicated for use as a non-invasive dermatological aesthetc treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.
    Device Description
    Erchonia® Verju™ Laser System with Massager
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    K Number
    K120257
    Device Name
    MLS, ZERONA-AD
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2012-05-14

    (108 days)

    Product Code
    OLI, GEX
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.
    Device Description
    Not Found
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    K Number
    K072206
    Device Name
    ERCHONIA EML LASER
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2008-04-24

    (260 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.
    Device Description
    Not Found
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    K Number
    K062792
    Device Name
    ERCHONIA IOTO_240
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2007-03-01

    (164 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia IOTO_240 is a galvanic generator that is indicated for use in tap water iontophoresis to treat palmer hyperhidrosis and plantar hyperhidrosis.
    Device Description
    The Erchonia IOTO_240 is a galvanic generator.
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    K Number
    K050672
    Device Name
    ERCHONIA EVRL LASER
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2005-05-02

    (48 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia EVRL Laser is generally indicated: - while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and - b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
    Device Description
    Erchonia EVRL Laser
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    K Number
    K041139
    Device Name
    ERCHONIA EML LASER
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2004-09-30

    (153 days)

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

    ERCHONIA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process.
    Device Description
    Not Found
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