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FDA 510(k) Application Details - K163329
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K163329
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
PULSADERM LLC
12801 COMMONWEALTH DR. UNITS 2-6
Fort Myers, FL 33913 US
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Contact
Gloria Avendano
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHS
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More FDA Info for this Product Code
Date Received
11/28/2016
Decision Date
04/14/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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