K253333
- 510(k) number
- K253333
- Device name
- Assisted Reproduction Laser System (Model ILS-400M)
- Applicant
- Hua Yue Medical Technology Co., Ltd. CN
- Product code
- MRX — System, Assisted Reproduction Laser
- Decision date
- 2026-06-17
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253333.pdf
Official FDA record: K253333
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.