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FDA 510(k)

Nd:Yag Laser Therapy Systems

K-Number: K232532 · 2023-11-02

ApplicantBeijing Unt Technology Co., Ltd.
Decision Date2023-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nd:Yag Laser Therapy Systems is a medical device manufactured by Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-02 under approval number K232532. 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?

Nd:Yag Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Beijing Unt Technology Co., Ltd.. The 510(k) number is K232532.

When was Nd:Yag Laser Therapy Systems approved by the FDA?

Nd:Yag Laser Therapy Systems received FDA 510(k) clearance on 2023-11-02, under approval number K232532.

What company makes Nd:Yag Laser Therapy Systems?

Nd:Yag Laser Therapy Systems is manufactured by Beijing Unt Technology Co., Ltd..

What is the FDA product code for Nd:Yag Laser Therapy Systems?

The FDA product code for Nd:Yag Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

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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 Beijing Unt Technology Co., Ltd.

K212978Diode laser therapy system

Related Devices (Code: GEX)

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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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