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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 K252877
Device Name SANDRO Dual
Applicant
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Applicant Contact Hyunsik Yoon
Correspondent
Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu
64, Techno 8-Ro, Yuseong-Gu,  KR 34028
Correspondent Contact Hyunsik Yoon
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/10/2025
Decision Date 12/19/2025
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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