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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 K260632
Device Name LASER THERMAL THERAPY KIT
Applicant
Elesta S.P.A
Via Arsiero Salvanti 41/43
Calenzano,  IT 50041
Applicant Contact Alessia Blundo
Correspondent
DuVal & Associates
825 Nicollet Mall, Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Jenifer Ulrikson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/26/2026
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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