Assisted Reproduction Laser System (Model ILS-400M)
K-Number: K253333 · 2026-06-17
Device Summary
Frequently Asked Questions
What is the Assisted Reproduction Laser System (Model ILS-400M)?
Assisted Reproduction Laser System (Model ILS-400M) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K253333.
When did Assisted Reproduction Laser System (Model ILS-400M) receive FDA 510(k) clearance?
Assisted Reproduction Laser System (Model ILS-400M) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253333.
Who is the listed applicant for Assisted Reproduction Laser System (Model ILS-400M)?
The FDA 510(k) record lists Hua Yue Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Assisted Reproduction Laser System (Model ILS-400M)?
The FDA product code for Assisted Reproduction Laser System (Model ILS-400M) is MRX.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Hua Yue Medical Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MRX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.