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FDA 510(k) Application Details - K020591
Device Classification Name
Light, Ultraviolet, Dermatological
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510(K) Number
K020591
Device Name
Light, Ultraviolet, Dermatological
Applicant
LUMENIS
1249 QUARRY LN.
SUITE 100
PLEASANTON, CA 94566-3403 US
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Contact
C. ROBERT PAYNE JR.
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Regulation Number
878.4630
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Classification Product Code
FTC
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More FDA Info for this Product Code
Date Received
02/22/2002
Decision Date
05/16/2002
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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