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FDA 510(k)

Nd: YAG Laser Therapy Systems HM-YL900

K-Number: K202758 · 2020-11-16

ApplicantShangdong Huamei Technology Co., Ltd.
Decision Date2020-11-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nd: YAG Laser Therapy Systems HM-YL900 is a medical device manufactured by Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-16 under approval number K202758. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nd: YAG Laser Therapy Systems HM-YL900?

Nd: YAG Laser Therapy Systems HM-YL900 is a medical device that received FDA 510(k) clearance on 2020-11-16. It is manufactured by Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K202758.

When was Nd: YAG Laser Therapy Systems HM-YL900 approved by the FDA?

Nd: YAG Laser Therapy Systems HM-YL900 received FDA 510(k) clearance on 2020-11-16, under approval number K202758.

What company makes Nd: YAG Laser Therapy Systems HM-YL900?

Nd: YAG Laser Therapy Systems HM-YL900 is manufactured by Shangdong Huamei Technology Co., Ltd..

What is the FDA product code for Nd: YAG Laser Therapy Systems HM-YL900?

The FDA product code for Nd: YAG Laser Therapy Systems HM-YL900 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Shangdong Huamei Technology Co., Ltd.

K192521Intense Pulsed Light Treatment System K192528CO2 Laser Therapy System K200751Photodynamic Therapy (PDT) Equipment K230816Intense Pulsed Light Treatment System

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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.

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