FDA.reportPublic FDA data

510(k) K254004

Device
VRNT
Applicant
Cognifisense, Inc.
510(k) number
K254004
Product code
QRA
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-10
Date received
2025-12-15
Regulation
890.5800
Classification name
Virtual Reality Behavioral Therapy Device For Pain Relief
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Amanda Way
Address
1271 Lakeside Dr. Apt. 3121 Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QRA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251519RelieVRx (Pico G3)Appliedvr2025-08-13
K243417RelieVRxAppliedvr2024-12-04
K230814VRNTCognifisense, Inc.2023-10-31
K230825Smileyscope System (Therapy Mode)Smileyscope Holding, Inc.2023-09-25
DEN210014EaseVRxAppliedvr, Inc.2021-11-16