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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 K220793
Device Name InnoVoyce Laser Fiber
Applicant
Innovoyce, LLC
25 Dorchester Ave., Suite #52318
Boston,  MA  02205
Applicant Contact Kent Johnson
Correspondent
Labcorp
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact Cori Ragan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/18/2022
Decision Date 05/25/2022
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
Predetermined Change
Control Plan Authorized		 No
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