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FDA 510(k) Application Details - K170260
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
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510(K) Number
K170260
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
Oriental Inspiration Limited
Unit 607, The Lakeside 2, West Wing, No. 10
Science Park West Avenue
Hong Kong CN
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Contact
Andy Wu
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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
01/27/2017
Decision Date
04/25/2017
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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