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FDA 510(k) Application Details - K111286
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
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510(K) Number
K111286
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
SILVER BAY, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE, TN 37922 US
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Contact
ROBERT WAGNER
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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
05/06/2011
Decision Date
01/18/2012
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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