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FDA 510(k)

eLens 硬性透气性隐形眼镜,适用于日常佩戴,eLens 硬性透气性隐形眼镜,适用于日常佩戴和正畸治疗

K号: K181579 · 2018-07-26

决定日期2018-07-26
产品代码HQD
咨询委员会OP 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:HQD)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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