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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 K251077
Device Name JOULE 1064nm System and Accessories
Applicant
Sciton, Inc
925 Commercial St.
Palo Alto,  CA  94303
Applicant Contact Jay Patel
Correspondent
Sciton, Inc
925 Commercial St.
Palo Alto,  CA  94303
Correspondent Contact Jay Patel
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/08/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT04744935
NCT05138328
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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