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

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..

Clearance details

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

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