OptiLux LED照明器
K 號：K163185 · 2016-11-21
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器材摘要
OptiLux LED Illuminator is the device name listed in this FDA 510(k) record. The listed applicant is Isolux, LLC. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K163185. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OptiLux LED Illuminator?
OptiLux LED Illuminator is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Isolux, LLC. The 510(k) number is K163185.
When did OptiLux LED Illuminator receive FDA 510(k) clearance?
OptiLux LED Illuminator received FDA 510(k) clearance on 2016-11-21, under 510(k) number K163185.
Who is the listed applicant for OptiLux LED Illuminator?
The FDA 510(k) record lists Isolux, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptiLux LED Illuminator?
The FDA product code for OptiLux LED Illuminator is HBI.
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相關器械（代碼：HBI）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
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