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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 K242946
Device Name HESTIA (L200-A)
Applicant
Senbitec Co., Ltd.
304, 46-24 Ls-Ro 91beon-Gil, Dongan-Gu
Anyang-Si,  KR
Applicant Contact Ga Hee Han
Correspondent
Mtech Group, LLC
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2024
Decision Date 10/03/2025
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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