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)

FIJI SUN FLUORESCENT TANNING UNIT

Número K: K151721 · 2018-06-22

RequerenteKdb Inc. (Dba) Sperti Sunlamp
Data da decisão2018-06-22
Código do produtoLEJ
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

FIJI SUN FLUORESCENT TANNING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Kdb Inc. (Dba) Sperti Sunlamp. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K151721. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FIJI SUN FLUORESCENT TANNING UNIT?

FIJI SUN FLUORESCENT TANNING UNIT is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Kdb Inc. (Dba) Sperti Sunlamp. The 510(k) number is K151721.

When did FIJI SUN FLUORESCENT TANNING UNIT receive FDA 510(k) clearance?

FIJI SUN FLUORESCENT TANNING UNIT received FDA 510(k) clearance on 2018-06-22, under 510(k) number K151721.

Who is the listed applicant for FIJI SUN FLUORESCENT TANNING UNIT?

The FDA 510(k) record lists Kdb Inc. (Dba) Sperti Sunlamp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIJI SUN FLUORESCENT TANNING UNIT?

The FDA product code for FIJI SUN FLUORESCENT TANNING UNIT is LEJ.

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: LEJ)

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.

K221523Tanning LampUnilam Co., Ltd.K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbHK191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH

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.

↑