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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 K171079
Device Name Q-Switched Nd:YAG Laser System
Applicant
Ids, Ltd.
#105, Byoksan Digital Valley 3 Cha 271, Digital-Ro, Guro-Gu
Seoul,  KR
Applicant Contact C. J. Park
Correspondent
Braunsolutions
970 S. Dawson Way, Unit 14
Aurora,  CO  80012
Correspondent Contact Alexander Braun Henderson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/11/2017
Decision Date 08/01/2017
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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