FDA 510(k)

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Número K: K191929 · 2019-09-17

Data da decisão2019-09-17

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K191929. 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 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Unicon Optical Co., Ltd.. The 510(k) number is K191929.

When did UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2019-09-17, under 510(k) number K191929.

Who is the listed applicant for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

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

What is the FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for UNICON Hydrogel (Hioxifilcon A) 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 Unicon Optical Co., Ltd. como candidato(a)

K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

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.