K230825
- 510(k) number
- K230825
- Device name
- Smileyscope System (Therapy Mode)
- Applicant
- Smileyscope Holding, Inc. TX · US
- Product code
- QRA — Virtual Reality Behavioral Therapy Device For Pain R
- Decision date
- 2023-09-25
- Date received
- 2023-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K230825.pdf
Official FDA record: K230825
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.