FDA 510(k)

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

Número K: K171404 · 2017-07-17

Data da decisão2017-07-17

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K171404. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K171404.

When did BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) receive FDA 510(k) clearance?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) received FDA 510(k) clearance on 2017-07-17, under 510(k) number K171404.

Who is the listed applicant for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is HQD.

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 Bausch + Lomb, Incorporated como candidato(a)

K230954Samfilcon B Custom Contact Lens K211786Independent Corneal Viewing Chamber (IVC-21)K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

Dispositivos Relacionados (Código: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) e Acuity 181™ (tisilfocon A) com Tangible™ Hydra-PEG® Rígido Gas Permeável Lentes de ContatoAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 200® (fluoroxyfocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 100® (hexafocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 200® com Tangible® Hydra-PEG® (fluoroxyfocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 100® com Tangible® Hydra-PEG® (hexafocon A) Lente de Contato Rígida e Permeável ao GásAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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.