Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Enhanced AURORA™ Medical Diode System, and related accessories

N.º K: K230076 · 2023-03-08

SolicitantePsoria-Shield, Inc.
Fecha de decisión2023-03-08
Código de productoFTC
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Enhanced AURORA™ Medical Diode System, and related accessories is the device name listed in this FDA 510(k) record. The listed applicant is Psoria-Shield, Inc.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K230076. 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 Enhanced AURORA™ Medical Diode System, and related accessories?

Enhanced AURORA™ Medical Diode System, and related accessories is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Psoria-Shield, Inc.. The 510(k) number is K230076.

When did Enhanced AURORA™ Medical Diode System, and related accessories receive FDA 510(k) clearance?

Enhanced AURORA™ Medical Diode System, and related accessories received FDA 510(k) clearance on 2023-03-08, under 510(k) number K230076.

Who is the listed applicant for Enhanced AURORA™ Medical Diode System, and related accessories?

The FDA 510(k) record lists Psoria-Shield, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories?

The FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.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.

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.

↑