510(k) K261253 ยท OAP Laser, Comb, Hair
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
| Applicant | Ziree Co., Ltd., Changsha, CN |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | Apr 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261253
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.