FDA 510(k)

EyeGility™ Inserter for Preloaded enVista IOLs

N.º K: K242389 · 2024-10-10

Fecha de decisión2024-10-10

Código de productoMSS

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

EyeGility™ Inserter for Preloaded enVista IOLs 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 2024-10-10 under 510(k) number K242389. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EyeGility™ Inserter for Preloaded enVista IOLs?

EyeGility™ Inserter for Preloaded enVista IOLs is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K242389.

When did EyeGility™ Inserter for Preloaded enVista IOLs receive FDA 510(k) clearance?

EyeGility™ Inserter for Preloaded enVista IOLs received FDA 510(k) clearance on 2024-10-10, under 510(k) number K242389.

Who is the listed applicant for EyeGility™ Inserter for Preloaded enVista IOLs?

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 EyeGility™ Inserter for Preloaded enVista IOLs?

The FDA product code for EyeGility™ Inserter for Preloaded enVista IOLs is MSS.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Bausch & Lomb, Incorporated como solicitante

K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia K222541Gotas Lubricantes y de Humectación Sin Conservantes de Bausch + Lomb K202932ABT12 solución multipropósito K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

Ver todos los 17 dispositivos →

Dispositivos relacionados (Código: MSS)

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG K231106Accuject Refra Injector AR2900Medicel AG K231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.K212039CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.