510(k) K251519

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 13, 2025

Date Received

May 16, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Virtual Reality Behavioral Therapy Device For Pain Relief

Device Class

Class II

Regulation Number

890.5800

Review Panel

PM

Submission Type

A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content.