← Product Code [MRX](/productcode/MRX) · K253333

# Assisted Reproduction Laser System (Model ILS-400M) (K253333)

_Hua Yue Medical Technology Co., Ltd. · MRX · Jun 17, 2026 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253333

## Device Facts

- **Applicant:** Hua Yue Medical Technology Co., Ltd.
- **Product Code:** [MRX](/productcode/MRX.md)
- **Decision Date:** Jun 17, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.6200
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K253333](https://fda.innolitics.com/device/K253333)

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