510(k) K253333
K253333 is an FDA 510(k) premarket notification submitted by Hua Yue Medical Technology Co., Ltd. for the device "Assisted Reproduction Laser System (Model ILS-400M)". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code MRX (System, Assisted Reproduction Laser), a Class II device regulated under 21 CFR 884.6200. Hua Yue Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2026
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Assisted Reproduction Laser
- Device Class
- Class II
- Regulation Number
- 884.6200
- Review Panel
- OB
- Submission Type
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.