Assisted Reproduction Laser System (Model ILS-400M)
Device Facts
| Record ID | K253333 |
|---|---|
| Device Name | Assisted Reproduction Laser System (Model ILS-400M) |
| Applicant | Hua Yue Medical Technology Co., Ltd. |
| Product Code | MRX · Obstetrics/Gynecology |
| Decision Date | Jun 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.
