Clearance Summary
Assisted Reproduction Laser System (Model ILS-400M) received FDA 510(k) clearance under submission number K253333, sponsored by Hua Yue Medical Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-06-17.
- Submission: K253333
- Applicant / Sponsor: Hua Yue Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2026-06-17
Classification & Regulation
This clearance is catalogued under FDA product code MRX and 21 CFR 884.6200, within the Obstetrics/Gynecology review panel as a Class II device.