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FDA 510(k)

LED Therapy Device (QLXY-01)

K-Number: K261673 · 2026-09-17

ApplicantBeijing Nubway S&T Co., Ltd.
Decision Date2026-09-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Therapy Device (QLXY-01) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K261673. 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 LED Therapy Device (QLXY-01)?

LED Therapy Device (QLXY-01) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K261673.

When did LED Therapy Device (QLXY-01) receive FDA 510(k) clearance?

LED Therapy Device (QLXY-01) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261673.

Who is the listed applicant for LED Therapy Device (QLXY-01)?

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

What is the FDA product code for LED Therapy Device (QLXY-01)?

The FDA product code for LED Therapy Device (QLXY-01) is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Nubway S&T 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.

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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.

K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.

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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