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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

Número K: K181579 · 2018-07-26

RequerenteE&E Optics, Inc.
Data da decisão2018-07-26
Código do produtoHQD
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

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Fonte oficial

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