FDA 510(k) Application Details - K210965

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K210965
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant LED Technologies, Inc.
12821 Starkey Rd., Suite 4900
Largo, FL 33773 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 03/31/2021
Decision Date 12/15/2021
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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