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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K193072
Device Name Lucent : IPL
Applicant
Luvo Medical Technologies, Inc.
125 Fleming Dr.
Cambridge,  CA N1T 2B8
Applicant Contact Gregory Berzak
Correspondent
Luvo Medical Technologies, Inc.
125 Fleming Dr.
Cambridge,  CA N1T 2B8
Correspondent Contact Gregory Berzak
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
GEX  
Date Received11/04/2019
Decision Date 03/05/2020
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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