510(k) K253400 ยท OHS Light Based Over The Counter Wrinkle Reduction
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
| Applicant | Shenzhen Saidi Light Therapy Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 24, 2025 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253400
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.