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FDA 510(k)

Medical Diode Laser Systems (TR-B)

K-Number: K252658 · 2025-11-28

ApplicantBaoding Te'Anzhou Electronic Technology Co., Ltd.
Decision Date2025-11-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Systems (TR-B) is a medical device manufactured by Baoding Te'Anzhou Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-28 under approval number K252658. 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 Medical Diode Laser Systems (TR-B)?

Medical Diode Laser Systems (TR-B) is a medical device that received FDA 510(k) clearance on 2025-11-28. It is manufactured by Baoding Te'Anzhou Electronic Technology Co., Ltd.. The 510(k) number is K252658.

When was Medical Diode Laser Systems (TR-B) approved by the FDA?

Medical Diode Laser Systems (TR-B) received FDA 510(k) clearance on 2025-11-28, under approval number K252658.

What company makes Medical Diode Laser Systems (TR-B)?

Medical Diode Laser Systems (TR-B) is manufactured by Baoding Te'Anzhou Electronic Technology Co., Ltd..

What is the FDA product code for Medical Diode Laser Systems (TR-B)?

The FDA product code for Medical Diode Laser Systems (TR-B) is GEX. This falls under the Gastroenterology category.

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Other Devices by Baoding Te'Anzhou Electronic Technology Co., Ltd.

K252564Medical Diode Laser Systems (VeinCure)

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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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