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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter powered light based laser for acne
510(k) Number K160691
Device Name Acne Light Therapy Wand
Applicant
ZUKO, INC.
208 UPLAND WAY
Wayne,  PA  19087
Applicant Contact Jay Tapper
Correspondent
TEXAS APPLIED BIOMEDICAL SERVICES (T.A.B.S.)
12101 CULLEN BLVD, SUITE A
HOUSTON,  TX  77047
Correspondent Contact M.Joyce Heinrich
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/11/2016
Decision Date 06/21/2016
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
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