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FDA 510(k)

Diode laser therapy system

K-Number: K212978 · 2021-11-10

ApplicantBeijing Unt Technology Co., Ltd.
Decision Date2021-11-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser therapy system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212978. 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 system?

Diode laser therapy system is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Beijing Unt Technology Co., Ltd.. The 510(k) number is K212978.

When did Diode laser therapy system receive FDA 510(k) clearance?

Diode laser therapy system received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212978.

Who is the listed applicant for Diode laser therapy system?

The FDA 510(k) record lists Beijing Unt Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Beijing Unt 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.

K232532Nd:Yag Laser Therapy Systems

Related Devices (Code: GEX)

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.

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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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