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FDA 510(k) Application Details - K170111
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
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510(K) Number
K170111
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
Pulsaderm LLC
12801 COMMONWEALTH DR. UNITS 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
01/12/2017
Decision Date
05/08/2017
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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