K250195
- 510(k) number
- K250195
- Device name
- MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
- Applicant
- Matelaser, Inc. FL · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-05-30
- Date received
- 2025-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250195
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.