510(k) K250581 ยท OHS Light Based Over The Counter Wrinkle Reduction
KALA Red Light Face Mask (KALA-01)
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250581
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.