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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 K183566
Device Name CLARITY II Laser System
Applicant
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-Si,  KR 410220
Applicant Contact James Childs
Correspondent
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-Si,  KR 410220
Correspondent Contact James Childs
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/21/2018
Decision Date 06/14/2019
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
Recalls CDRH Recalls
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