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FDA 510(k) Application Details - K171390
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K171390
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
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2017
Decision Date
08/03/2017
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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