510(k) K253333 ยท MRX System, Assisted Reproduction Laser
Assisted Reproduction Laser System (Model ILS-400M)
| Applicant | Hua Yue Medical Technology Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253333
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.