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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 K123889
Device Name ACLEARA, THERACLEAR
Applicant
Theravant Corporation
131 Kelekent Lane
Cary,  NC  27518
Applicant Contact Marcy Moore
Correspondent
Theravant Corporation
131 Kelekent Lane
Cary,  NC  27518
Correspondent Contact Marcy Moore
Regulation Number878.4810
Classification Product Code
ONF  
Date Received12/18/2012
Decision Date 03/04/2013
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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