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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 K163196
Device Name ACTION II Laser System
Applicant
Lutronic Corporation
219, Sowon-Ro, Haengsin-Dong
Deogyang-Gu, Goyang-Si,  KR 410-722
Applicant Contact Jhung Won Vojir
Correspondent
Lutronic Corporation
6 Neshaminy Interplex, Suite 100
Trevose,  PA  19053
Correspondent Contact Jhung Won Vojir
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received11/15/2016
Decision Date 05/24/2017
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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