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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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More FDA Info for this Product Code
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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