FDA 510(k)

DT Controlled Phototherapy Equipment

Número K: K233811 · 2023-12-13

Data da decisão2023-12-13

Código do produtoFTC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DT Controlled Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K233811. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DT Controlled Phototherapy Equipment?

DT Controlled Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K233811.

When did DT Controlled Phototherapy Equipment receive FDA 510(k) clearance?

DT Controlled Phototherapy Equipment received FDA 510(k) clearance on 2023-12-13, under 510(k) number K233811.

Who is the listed applicant for DT Controlled Phototherapy Equipment?

The FDA 510(k) record lists Daavlin Distributing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DT Controlled Phototherapy Equipment?

The FDA product code for DT Controlled Phototherapy Equipment is FTC.

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Outros registros que listam Daavlin Distributing Co. como candidato(a)

K230382NeoLux da Série 3 K220840Equipamento de Fototerapia da Série 1 K212510Dispositivo de Fototerapia da Série 7 K210881M Series Phototherapy Equipment

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 Excimer de 308nm (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.

Fonte oficial

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