FDA 510(k)

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

Número K: K230990 · 2023-06-01

Data da decisão2023-06-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230990. 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 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Candela Corporation. The 510(k) number is K230990.

When did Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) receive FDA 510(k) clearance?

Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230990.

Who is the listed applicant for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

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

What is the FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)?

The FDA product code for Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) 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 Candela Corporation como candidato(a)

K240070Profound Matrix K220853PicoWay Laser System K212492Frax 1940 for Nordlys and Frax Pro K211217Profound Matrix K201111GentleMax Pro Plus K191685PicoWay Laser System

Ver todos os 7 dispositivos →

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.