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FDA 510(k)

Diode laser therapy device

K-Number: K232709 · 2023-11-30

ApplicantHebei Zhemai Technology Co., Ltd.
Decision Date2023-11-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser therapy device is a medical device manufactured by Hebei Zhemai Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under approval number K232709. 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 Diode laser therapy device?

Diode laser therapy device is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Hebei Zhemai Technology Co., Ltd.. The 510(k) number is K232709.

When was Diode laser therapy device approved by the FDA?

Diode laser therapy device received FDA 510(k) clearance on 2023-11-30, under approval number K232709.

What company makes Diode laser therapy device?

Diode laser therapy device is manufactured by Hebei Zhemai Technology Co., Ltd..

What is the FDA product code for Diode laser therapy device?

The FDA product code for Diode laser therapy device is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Other Devices by Hebei Zhemai Technology Co., Ltd.

K232708Intense pulsed light therapy device K232716Q-Switched Nd:Yag laser

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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