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510(k) Data Aggregation
K Number
K250195Device Name
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
Manufacturer
Date Cleared
2025-05-30
(127 days)
Regulation Number
878.4810Why 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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