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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K250281
Device Name DEKA LOTUS
Applicant
El.En S.P.A.
Via Baldanzese, 17
Calenzano,  IT 50041
Applicant Contact Peruzzi Paolo
Correspondent
El.En S.P.A.
Via Baldanzese, 17
Calenzano,  IT 50041
Correspondent Contact Peruzzi Paolo
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
GEI  
Date Received01/31/2025
Decision Date 02/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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