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510(k) Data Aggregation

    K Number
    K141237
    Device Name
    HARMONY LITE
    Manufacturer
    ALMA INC.
    Date Cleared
    2015-03-13

    (304 days)

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

    ALMA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications. Specific indications for use are listed for the following handpieces: - 500-600 nm Dye VL Pro Module AFT Hand piece: Treatment of benign cutaneous vascular lesions and use on Fitzpatrick skin types I-V. - 540-950 nm VP PRO AFT Hand piece: Treatment of benign pigmented epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI). - 570-950 nm SSR Pro Module AFT Hand piece: Treatment of benign pigmented epidermal lesions, face and body vascular and pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI). - 590 nm LED Module Handpiece: Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain, and provide topical heating for the purpose of elevating and/or maintaining tissue temperature. - 780-950 nm SHR PRO AFT Module Hand piece: Treatment of pseudofolliculitis barbae (PFB), removal of unwanted hair and to effect stable long-term or permanent hair reduction, and use on all skin types (Fitzpatrick I-VI), including tanned skin. - NIR Large and Small Modules: Temporary relief of minor muscle pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscle back pain. - Thermoelectric Cooler (TEC): Cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to reduce pain, discomfort, minimize thermal injury, allow the use of higher light or laser fluences, and reduce potential side effects.
    Device Description
    The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components: - The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. - Variety of handpieces, including IPL, LED and NIR modules - Footswitch.
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