FDA 510(k)

LED Therapy Device (QLXY-01)

Número K: K261673 · 2026-09-17

Data da decisão2026-09-17

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Beijing Nubway S&T Co., Ltd. como candidato(a)

K261841Q Switched Nd:YAG Laser machine (QLQW-01)K261693Diode laser hair removal machine (QDTM-04)K261674Skin Air Cooling System (QALF-01)K242951Diode laser hair removal machine (QDTM-02)K242943Q Switched Nd:YAG Laser machine (QNHF-01)

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.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 America

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.