FDA 510(k)

Ultraviolet Phototherapy Device

N.º K: K250425 · 2025-04-07

Fecha de decisión2025-04-07

Código de productoFTC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ultraviolet Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250425. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ultraviolet Phototherapy Device?

Ultraviolet Phototherapy Device is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K250425.

When did Ultraviolet Phototherapy Device receive FDA 510(k) clearance?

Ultraviolet Phototherapy Device received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250425.

Who is the listed applicant for Ultraviolet Phototherapy Device?

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

What is the FDA product code for Ultraviolet Phototherapy Device?

The FDA product code for Ultraviolet Phototherapy Device is FTC.

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 APK Technology Co., Ltd. como solicitante

K172981Reusable SpO2 Sensors, Disposable SpO2 Sensors K170536ECG Disposable Lead Wire

Dispositivos relacionados (Código: FTC)

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC K244022Sistema de Fototerapia UV de 308nm (UV-K); Sistema de Fototerapia UV de 308nm (UV-X); Sistema de Fototerapia UV de 308nm (UV-Y); Sistema de Fototerapia UV de 308nm (UV-Z)Boston Aesthetics, Inc.K242977Dispositivo de fototerapia de excímero de 308 nm (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.

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.