Assisted Reproduction Laser System (Model ILS-400M)
FDA 510(k) K253333 · Hua Yue Medical Technology Co., Ltd.
510(k) numberK253333
Submission
- Device name
- Assisted Reproduction Laser System (Model ILS-400M)
- Applicant
- Hua Yue Medical Technology Co., Ltd.
Guangzhou, CN - Received
- September 30, 2025
- Decision date
- June 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRX – System, Assisted Reproduction Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6200
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code MRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)MRX · Traditional | Hamilton Thorne, Inc. | 07/02/2021SE |
| K192008 | LaserShot M, NaviLaseMRX · Abbreviated | Vitrolife GmbH | 03/25/2020SE |
| K141434 | Saturn 5 LaserMRX · Traditional | Research Instruments , Ltd. | 02/18/2015SE |
| K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-Tk Hamilton Thorne Infrared Laser…MRX · Traditional | Hamilton Thorne, Inc. | 04/24/2012SE |
| K083208 | Saturn Active Laser SystemMRX · Abbreviated | Research Instruments , Ltd. | 08/25/2009SE |
| K063636 | Zilos-TkMRX · Traditional | Hamilton Thorne Biosciences | 04/24/2007SE |
| K060764 | Saturn 3 Laser SystemMRX · Traditional | Research Instruments , Ltd. | 03/12/2007SE |
| K062524 | Octax Laser Shot SystemMRX · Abbreviated | Minitube of America, Inc. | 12/15/2006SE |
| K050768 | Zilos-Tk, Version 3, Zilos-Tk, Version 4MRX · Special | Hamilton Thorne Biosciences | 04/28/2005SE |
More from Hamilton Thorne Biosciences
| 510(k) | Device | Decision |
|---|---|---|
| K242684 | Harioculture TL-16 Time-lapse IncubatorMQG · Traditional | 05/22/2025SE |
Questions and answers
When was Assisted Reproduction Laser System (Model ILS-400M) cleared by the FDA?
Assisted Reproduction Laser System (Model ILS-400M) (K253333) received a 510(k) decision of Substantially Equivalent on June 17, 2026, 260 days after the submission was received.
What is the product code of K253333?
The FDA product code is MRX – System, Assisted Reproduction Laser, a Class II (moderate risk) device regulated under 21 CFR 884.6200.