FDA 510(k)

UV Phototherapy

N.º K: K181805 · 2019-01-11

SolicitanteXuzhou Kernel Medical Equipment Co., Ltd.

Fecha de decisión2019-01-11

Código de productoFTC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

UV Phototherapy is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K181805. 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 UV Phototherapy?

UV Phototherapy is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K181805.

When did UV Phototherapy receive FDA 510(k) clearance?

UV Phototherapy received FDA 510(k) clearance on 2019-01-11, under 510(k) number K181805.

Who is the listed applicant for UV Phototherapy?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UV Phototherapy?

The FDA product code for UV Phototherapy is FTC.

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Otros registros que enlistan a Xuzhou Kernel Medical Equipment Co., Ltd. como solicitante

K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)K242977Dispositivo de fototerapia de excímero de 308 nm (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)K222751LED Light Therapy Device, KN-7000L K200971Sistema Excimer de 308nm K200929Hair Growth System K190685Hair Growth System

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: FTC)

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC K250425Ultraviolet 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

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