飞秒激光系统用于屈光矫正
PMA编号：P150040 · 2026-05-26
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决定日期2026-05-26
PMA 编号P150040
产品代码OTL
设备分类第3类
医疗专科U
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
Femtosecond laser system for refractive correction is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2026-05-26. The device is classified under product code OTL. It was reviewed by the OP advisory panel.
常见问题
What is the Femtosecond laser system for refractive correction?
Femtosecond laser system for refractive correction is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Carl Zeiss Meditec, Inc..
When did Femtosecond laser system for refractive correction receive FDA 510(k) clearance?
The clearance date for Femtosecond laser system for refractive correction can be found in the official FDA records.
Who is the listed applicant for Femtosecond laser system for refractive correction?
The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Femtosecond laser system for refractive correction?
The FDA product code for Femtosecond laser system for refractive correction is OTL.
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官方来源
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