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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K250731
Device Name MateLaser Medical Diode Laser Systems (ML-DLS-30)
Applicant
Matelaser, Inc.
3257 NW 7th Ave. Cir.
Miami,  FL  33127
Applicant Contact Ruth Garcia
Correspondent
Matelaser, Inc.
3257 NW 7th Ave. Cir.
Miami,  FL  33127
Correspondent Contact Ruth Garcia
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Codes
EEG   ILY  
Date Received03/11/2025
Decision Date 10/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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