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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 K191693
Device Name BC-5
Applicant
Reveallux, Corp
4508 38th, Suite 230
Columbus,  NE  68601
Applicant Contact Justin D Linn
Correspondent
FDA 510k Consultants, LLC
1100 Del Lago Cir. #104
Palm Beach Gardens,  FL  33410
Correspondent Contact John Gillespy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/25/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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