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FDA 510(k)

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

N.º K: K181579 · 2018-07-26

SolicitanteE&E Optics, Inc.
Fecha de decisión2018-07-26
Código de productoHQD
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is the device name listed in this FDA 510(k) record. The listed applicant is E&E Optics, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181579. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is E&E Optics, Inc.. The 510(k) number is K181579.

When did eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K receive FDA 510(k) clearance?

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181579.

Who is the listed applicant for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

The FDA 510(k) record lists E&E Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K?

The FDA product code for eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K is HQD.

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Dispositivos relacionados (Código: HQD)

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.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Lentes de Contacto Rígidas Gas Permeables Acuity 181™ (tisilfocon A) y Acuity 181™ (tisilfocon A) con Tangible™ Hydra-PEG®Acuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Lente de Contacto Rígida Gas Permeable Acuity 200™ (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ (hexafocon A); Lente de Contacto Rígida Gas Permeable Acuity 200™ con Tangible® Hydra-PEG® (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ con Tangible® Hydra-PEG® (hexafocon A)Acuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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.

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