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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 the device name listed in this FDA 510(k) record. The listed applicant is Baoding Te'Anzhou Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-28 under 510(k) 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. The listed applicant is Baoding Te'Anzhou Electronic Technology Co., Ltd.. The 510(k) number is K252658.

When did Medical Diode Laser Systems (TR-B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Diode Laser Systems (TR-B)?

The FDA 510(k) record lists Baoding Te'Anzhou Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Baoding Te'Anzhou Electronic 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.

K252564Medical Diode Laser Systems (VeinCure)

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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