Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)

Número K: K223882 · 2023-03-27

RequerenteShenzhen Honpal Optoelectronic Technology Co., Ltd.
Data da decisão2023-03-27
Código do produtoFTC
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223882. 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 Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The 510(k) number is K223882.

When did Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) receive FDA 510(k) clearance?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223882.

Who is the listed applicant for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

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

What is the FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is FTC.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑