510(k) K250761 ยท OHS Light Based Over The Counter Wrinkle Reduction
KALA Therapy Wand (Model: KALA-03)
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Mar 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250761
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.