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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 K124042
Device Name TANDA MINI SKINCARE SYSTEM
Applicant
SYNERON BEAUTY
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
SYNERON BEAUTY
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number878.4810
Classification Product Code
OLP  
Date Received12/28/2012
Decision Date 04/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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