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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K212222
Device Name Soniquence Reusable 3 Button Fingerswitch Wand
Applicant
Soniquence, LLC
2477 Grand Ave.
Baldwin,  NY  11510
Applicant Contact Suzanne Lucas
Correspondent
Soniquence, LLC
2477 Grand Ave.
Baldwin,  NY  11510
Correspondent Contact Suzanne Lucas
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/16/2021
Decision Date 09/02/2022
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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