FDA.reportPublic FDA data

510(k) K243150

Device
Nuance Audio Hearing Aid Software
Applicant
Luxottica Group S.P.A.
510(k) number
K243150
Product code
SCR
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-31
Date received
2024-09-30
Regulation
874.3335
Classification name
Air-Conduction Hearing Aid Software
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Giulia Cuccato
Address
Piazzale Cadorna 3 Milan IT 20123 20123

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SCR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251208Tuned Self-Fitting Mobile AppTuned , Ltd.2025-09-26
DEN230081Hearing Aid Feature (HAF)Apple, Inc.2024-09-12