Cleared Traditional

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

K250195 · Matelaser, Inc. · General & Plastic Surgery

May 2025

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K250195 is an FDA 510(k) clearance for the MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60), a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Matelaser, Inc. (Miami, US). The FDA issued a Cleared decision on May 30, 2025, 127 days after receiving the submission on January 23, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K250195 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2025
Decision Date	May 30, 2025
Days to Decision	127 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.