FDA.reportPublic FDA data

510(k) K254044

Device
Hearing assist
Applicant
Meta Platform Technologies, LLC
510(k) number
K254044
Product code
SCR
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-13
Date received
2025-12-17
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
N

Applicant Contact#

Contact
Lucas Fernandez
Address
333 Airport Blvd. Burlingame CA US 94010 94010

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
K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.2025-01-31
DEN230081Hearing Aid Feature (HAF)Apple, Inc.2024-09-12