FDA 510(k) Application Details - K050080

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K050080
Device Name Light, Ultraviolet, Dermatological
Applicant CYNOSURE, INC.
10 ELIZABETH DR.
CHELMSFORD, MA 01824 US
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Contact GEORGE CHO
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 01/13/2005
Decision Date 05/05/2005
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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