510(k) K230825 ยท QRA Virtual Reality Behavioral Therapy Device For Pain Relief
Smileyscope System (Therapy Mode)
| Applicant | Smileyscope Holding, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 25, 2023 |
| Received | Mar 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230825
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.