Manufacturer
Matelaser, Inc.MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250195
- Device name
- MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
- Company
- Matelaser, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-23
- Decision date
- 2025-05-30
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatmentAcne treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
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. 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. 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.)
Intended Use
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. 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. 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.)
Summary parsed at:2026-06-01 05:22:18 UTC
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