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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 K222485
Device Name SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
Applicant
Ids, Limited
194, Simgung-Ro, Gwangtan-Myeon, Paju-Si,
Gyeonggi-Do,  KR 10952
Applicant Contact K.Y. Ahn
Correspondent
Braunsolutions Regulatory Group
2298 Americus Blvd. E. Unit 14
Clearwayer,  FL  33763
Correspondent Contact Alexander Braun Henderson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/17/2022
Decision Date 03/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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