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FDA 510(k) Application Details - K161941
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
More FDA Info for this Device
510(K) Number
K161941
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
NUTRA LUXE MD, LLC
12801 COMMONWEALTH DR.
UNIT 2-6
FORT MYERS, FL 33913 US
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Contact
GLORIA AVENDANO
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Regulation Number
878.4810
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Classification Product Code
OLP
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More FDA Info for this Product Code
Date Received
07/15/2016
Decision Date
10/19/2016
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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