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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
510(k) Number K103626
Device Name CUTERA GENESISPLUS LASER SYSTEM
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
PDZ  
Subsequent Product Code
GEX  
Date Received12/10/2010
Decision Date 04/05/2011
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
Predetermined Change
Control Plan Authorized		 No
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