FDA 510(k)

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)

Número K: K182453 · 2019-01-11

Data da decisão2019-01-11

Código do produtoNUV

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) is the device name listed in this FDA 510(k) record. The listed applicant is I-Tech Industries Srl. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182453. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)?

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is I-Tech Industries Srl. The 510(k) number is K182453.

When did ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) receive FDA 510(k) clearance?

ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182453.

Who is the listed applicant for ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)?

The FDA 510(k) record lists I-Tech Industries Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)?

The FDA product code for ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) is NUV.

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 I-Tech Industries Srl como candidato(a)

K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)

Dispositivos Relacionados (Código: NUV)

K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K231092T-SHAPE 2B&M S.R.L. Marketing Nel Benessere K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl K161892Slimming Treatment DeviceBeijing Honkon Technologies 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.