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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 K101916
Device Name JOULE MULTI-PLATFORM SYSTEM
Applicant
Sciton, Inc
925 Commercial St.
Palo Alto,  CA  94303
Applicant Contact JAY M PATEL
Correspondent
Sciton, Inc
925 Commercial St.
Palo Alto,  CA  94303
Correspondent Contact JAY M PATEL
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   ONG   ORK  
Date Received07/09/2010
Decision Date 03/18/2011
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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