FDA 510(k)

Diode laser system (Night Universe; Predator)

Número K: K250206 · 2025-04-24

RequerenteIvylaser (Beijing) Technology Co.,Ltd

Data da decisão2025-04-24

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diode laser system (Night Universe; Predator) is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250206. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Diode laser system (Night Universe; Predator)?

Diode laser system (Night Universe; Predator) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K250206.

When did Diode laser system (Night Universe; Predator) receive FDA 510(k) clearance?

Diode laser system (Night Universe; Predator) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250206.

Who is the listed applicant for Diode laser system (Night Universe; Predator)?

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

What is the FDA product code for Diode laser system (Night Universe; Predator)?

The FDA product code for Diode laser system (Night Universe; Predator) is GEX. This falls under the Gastroenterology category.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Ivylaser (Beijing) Technology Co.,Ltd como candidato(a)

K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)K230025IVYLASER Handhold Hair Removal Machine

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T 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.