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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 Avenue, Ste #52318
Boston,  MA  02205
Applicant Contact Kent Johnson
Correspondent
Labcorp
5353 Wayzata Boulevard, Suite 505
Minneapolis,  MN  55416 -1334
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
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