FDA 510(k) Application Details - K171386

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K171386
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant LED Technologies, Inc.
6000 Greenwood Plaza Blvd., Suite 110
Greenwood Village, CO 80111 US
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Contact Lloyd Nelson
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 05/11/2017
Decision Date 08/07/2017
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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