FDA 510(k) Application Details - K103626

Device Classification Name

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510(K) Number K103626
Device Name CUTERA GENESISPLUS LASER SYSTEM
Applicant CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE, CA 94005 US
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Contact Connie Hoy
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Regulation Number

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Classification Product Code PDZ
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Date Received 12/10/2010
Decision Date 04/05/2011
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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