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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air-Conduction Hearing Aid Software
510(k) Number K243150
Device Name Nuance Audio Hearing Aid Software
Applicant
Luxottica Group S.P.A.
Piazzale Cadorna 3
Milan,  IT 20123
Applicant Contact Giulia Cuccato
Correspondent
Luxottica Group S.P.A.
Piazzale Cadorna 3
Milan,  IT 20123
Correspondent Contact John Luna
Classification Product Code
SCR  
Date Received09/30/2024
Decision Date 01/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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