Matelaser, Inc. · Class II · Cleared May 30, 2025
| K-number | K250195 |
| Device name | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) |
| Applicant | Matelaser, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | May 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) are laser devices that emit energy at 810 nm and 980 nm wavelengths. The ML-HIL-30 is used for topical heating to provide temporary relief of minor muscle and joint pain, stiffness, arthritis pain, and muscle spasm. The ML-HIL-60 has expanded surgical applications including hemostasis, ablation, vaporization, excision, incision, and coagulation across multiple specialties (dermatology, gastroenterology, general surgery, gynecology, etc.), and treatment of onychomycosis.
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View the full FDA submission: accessdata.fda.gov