FDA 510(k) Application Details - K172555

Device Classification Name Over-The-Counter Powered Light Based Laser For Acne

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510(K) Number K172555
Device Name Over-The-Counter Powered Light Based Laser For Acne
Applicant Omm Imports, Inc. d/b/a Zero Gravity
9737 NW 41St Street
Doral, FL 33178 US
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Contact Zivan Habibi
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Regulation Number 878.4810

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Classification Product Code OLP
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Date Received 08/24/2017
Decision Date 05/01/2018
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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