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.

Summary

Hua Yue Medical Technology's Assisted Reproduction Laser System (Model ILS-400M) is filed under MRX, assisted reproduction laser systems. The record doesn't describe it beyond the model number and the code name.

Class II, 21 CFR 884.6200. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Hua Yue filed from Guangzhou, China. The decision came 260 calendar days after receipt (September 30, 2025 to June 17, 2026).

Clearance details

Applicant: Hua Yue Medical Technology Co., Ltd.
Product code: Product 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 ↗

Recent devices under product code MRX

view all

K202241 — LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)2021-07-02
K192008 — LaserShot M, NaviLase2020-03-25
K141434 — SATURN 5 LASER2015-02-18
K120055 — HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS2012-04-24
K083208 — SATURN ACTIVE LASER SYSTEM2009-08-25

More clearances from Hua Yue Medical Technology Co., Ltd.

view all

K242684 — Harioculture TL-16 Time-lapse Incubator2025-05-22

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