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510(k) Data Aggregation

    K Number
    K250195
    Device Name
    MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
    Manufacturer
    Date Cleared
    2025-05-30

    (127 days)

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

    MateLaser, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    **810 nm and 980 nm wavelength:** MateLaser Medical Laser Therapy Systems (Model: ML HIL 30/60) emit energy in the invisible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. **980 nm wavelength:** MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis. **980 nm wavelength:** MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
    Device Description
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