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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 K161503
Device Name ORION
Applicant
Yerim Engineering Co., Ltd.
Ga-307, Techno-Zone ,117, Hwanggeum-Ro, Yangchon-Eup
Gimpo-Si,  KR 415843
Applicant Contact Won Gil Jeon
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/01/2016
Decision Date 08/26/2016
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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