Cleared Traditional

MateLaser Medical Diode Laser Systems (ML-DLS-30)

K250731 · Matelaser, Inc. · Dental

Oct 2025

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K250731 is an FDA 510(k) clearance for the MateLaser Medical Diode Laser Systems (ML-DLS-30), a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Matelaser, Inc. (Miami, US). The FDA issued a Cleared decision on October 16, 2025, 219 days after receiving the submission on March 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K250731 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2025
Decision Date	October 16, 2025
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.