Assisted Reproduction Laser System (Model ILS-400M)— 510(k) K253333

Name: FDA 510(k) clearance K253333
Creator: U.S. Food and Drug Administration
Published: 2026-06-17

Substantially Equivalent

Hua Yue Medical Technology Co., Ltd.

FDA 510(k) clearance K253333 for Assisted Reproduction Laser System (Model ILS-400M), Substantially Equivalent on 2026-06-17. Applicant: Hua Yue Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hua Yue Medical Technology Co., Ltd.
Product code: Code MRX
Device class: Class 2
Regulation: 21 CFR 884.6200
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-30
Decision date: 2026-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.