可调光镜（LAL）和光输送设备（LDD）
PMA编号：P160055 · 2026-09-03
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决定日期2026-09-03
PMA 编号P160055
产品代码PZK
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
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器械摘要
Light adjustable lens (LAL) and light delivery device (LDD) is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2026-09-03. The device is classified under product code PZK. It was reviewed by the OP advisory panel.
常见问题
What is the Light adjustable lens (LAL) and light delivery device (LDD)?
Light adjustable lens (LAL) and light delivery device (LDD) is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Rxsight, Inc..
When did Light adjustable lens (LAL) and light delivery device (LDD) receive FDA 510(k) clearance?
The clearance date for Light adjustable lens (LAL) and light delivery device (LDD) can be found in the official FDA records.
谁是被列为Light adjustable lens（LAL）和light delivery device（LDD）的申请人？
The FDA 510(k) record lists Rxsight, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是Light adjustable lens（LAL）和light delivery device（LDD）的FDA产品代码？
FDA产品代码为Light adjustable lens（LAL）和light delivery device（LDD）的是PZK。
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官方来源
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