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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K260647
Device Name SPECCHIO
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 Number878.4400
Classification Product Code
PBX  
Date Received02/27/2026
Decision Date 04/02/2026
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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