510(k) K230825

Device

Smileyscope System (Therapy Mode)

Applicant

Smileyscope Holding, Inc.

510(k) number

K230825

Product code

QRA

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-25

Date received

2023-03-24

Regulation

890.5800

Classification name

Virtual Reality Behavioral Therapy Device For Pain Relief

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No