FDA 510(k)

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens

Número K: K182523 · 2018-11-01

Data da decisão2018-11-01

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182523. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens?

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K182523.

When did Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182523.

Who is the listed applicant for Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens?

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

What is the FDA product code for Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA product code for Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is LPL.

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 Largan Medical Co., Ltd. como candidato(a)

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: LPL)

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.