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FDA 510(k) Application Details - K202055
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
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510(K) Number
K202055
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
Heat In A Click LLC
1975 Tigertail Blvd Dania
Homestead, FL 33034 US
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Contact
Guy Levi
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Regulation Number
878.4810
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Classification Product Code
OLP
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More FDA Info for this Product Code
Date Received
07/24/2020
Decision Date
04/16/2021
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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