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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 K213594
Device Name ECHOLASER X4
Applicant
ELESTA SPA
Via Baldanzese 17
Calenzano,  IT 50041
Applicant Contact Fabio Andreola
Correspondent
Maurizio Pantaleoni
Via Borgo Santa Cristina 12
Imola,  IT 40026
Correspondent Contact Maurizio Pantaleoni
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/12/2021
Decision Date 05/03/2022
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
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