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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K122493
Device Name GENESISPLUS
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Applicant Contact Connie Hoy
Correspondent
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
PDZ  
Date Received08/16/2012
Decision Date 05/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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