FDA 510(k) Application Details - K170269

Device Classification Name Light Based Over-The-Counter Hair Removal

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510(K) Number K170269
Device Name Light Based Over-The-Counter Hair Removal
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 OHT
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Date Received 01/27/2017
Decision Date 05/03/2017
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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