Nuance Audio Hearing Aid Software— 510(k) K243150

Name: FDA 510(k) clearance K243150
Creator: U.S. Food and Drug Administration
Published: 2025-01-31

Substantially Equivalent

Luxottica Group S.P.A.

FDA 510(k) clearance K243150 for Nuance Audio Hearing Aid Software, Substantially Equivalent on 2025-01-31. Applicant: Luxottica Group S.P.A.. Device class: 2.

Clearance details

Applicant: Luxottica Group S.P.A.
Product code: Code SCR
Device class: Class 2
Regulation: 21 CFR 874.3335
Advisory panel: Ear, Nose, Throat
Date received: 2024-09-30
Decision date: 2025-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.