K230825 is an FDA 510(k) clearance for the Smileyscope System (Therapy Mode). This device is classified as a Virtual Reality Behavioral Therapy Device For Pain Relief (Class II - Special Controls, product code QRA).
Submitted by Smileyscope Holding, Inc. (Austin, US). The FDA issued a Cleared decision on September 25, 2023, 185 days after receiving the submission on March 24, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5800. 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..
| 510(k) Number | K230825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2023 |
| Decision Date | September 25, 2023 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | QRA - Virtual Reality Behavioral Therapy Device For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5800 |
| Definition | 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. |