FDA 510(k)

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Número K: K261775 · 2026-07-21

RequerenteXuzhou Kernel Medical Equipment Co., Ltd.

Data da decisão2026-07-21

Código do produto

DecisãoSubstantially Equivalent

Resumo do dispositivo

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) 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 2026-07-21 under 510(k) number K261775. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)?

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K261775.

Quando a Uv Fototerapia (KN-4001A, KN-4001B, KN-4001AB) recebeu a aprovação FDA 510(k)?

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) received FDA 510(k) clearance on 2026-07-21, under 510(k) number K261775.

Who is the listed applicant for Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)?

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

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Outros registros que listam Xuzhou Kernel Medical Equipment Co., Ltd. como candidato(a)

K242977Dispositivo de Fototerapia de Excimer de 308nm (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 K181805UV Phototherapy

Ver todos os 8 dispositivos →

Fonte oficial

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