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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K242859
Device Name VEGA
Applicant
Ibramed Equipamentos Médicos
Av. Dr. Carlos Burgos, 2800
Jardim Itália
Amparo,  BR 13901-080
Applicant Contact Fabio Alexandre Pinto
Correspondent
United Regulatory & Logistics, LLC
12343 NW 25th St.
Coral Springs,  FL  33065
Correspondent Contact Rodrigo Abreu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/20/2024
Decision Date 09/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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