扩展焦深人工晶状体
PMA编号：P210005 · 2026-07-14
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决定日期2026-07-14
PMA 编号P210005
产品代码POE
设备分类第3类
医疗专科O
法规编号21 CFR 8
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。
器械摘要
Extended depth of focus intraocular lens is the device name listed in this FDA 510(k) record. The listed applicant is Acu Focus, Inc.. It received FDA 510(k) clearance on 2026-07-14. The device is classified under product code POE. It was reviewed by the OP advisory panel.
常见问题
What is the Extended depth of focus intraocular lens?
Extended depth of focus intraocular lens is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Acu Focus, Inc..
When did Extended depth of focus intraocular lens receive FDA 510(k) clearance?
The clearance date for Extended depth of focus intraocular lens can be found in the official FDA records.
Who is the listed applicant for Extended depth of focus intraocular lens?
The FDA 510(k) record lists Acu Focus, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Extended depth of focus intraocular lens?
The FDA product code for Extended depth of focus intraocular lens is POE.
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官方来源
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