VRNT— 510(k) K254004
Substantially EquivalentCognifisense, Inc.
FDA 510(k) clearance K254004 for VRNT, Substantially Equivalent on 2026-04-10. Applicant: Cognifisense, Inc.. Device class: 2.
Summary
VRNT is filed under QRA, virtual reality behavioral therapy devices for pain relief. Cognifisense builds VR programs for chronic pain, so the code matches the company's focus.
Class II, 21 CFR 890.5800, reviewed by the Neurology panel. It's a Special 510(k), which means Cognifisense was modifying a device it already had cleared.
The company filed from Sunnyvale, California. Review took 116 days (December 15, 2025 to April 10, 2026). QRA is a young code: FDA created it in 2021, when it authorized the first VR pain therapy through De Novo.
Clearance details
- Applicant
- Cognifisense, Inc.
- Product code
- Code QRA
- Device class
- Class 2
- Regulation
- 21 CFR 890.5800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code QRA
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