FDA 510(k)

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

N.º K: K261817 · 2026-09-17

SolicitanteZhengzhou PZ Laser Slim Technology Co., Ltd.

Fecha de decisión2026-09-17

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K261817. 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.

Preguntas frecuentes

What is the Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K261817.

When did Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) receive FDA 510(k) clearance?

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261817.

Who is the listed applicant for Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim 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 (PZ-BDT67-01, PZ-BDT67-02)?

The FDA product code for Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) is GEX. This falls under the Gastroenterology category.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Zhengzhou PZ Laser Slim Technology Co., Ltd. como solicitante

K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)K252732Sistema de Laser de Tio Aluminio a 1927nm (PZ-DJG75-01, PZ-DJG75-02)K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)K250782Fractional CO2 Laser Machine

Ver todos los 10 dispositivos →

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.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.