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K 號：K210948 · 2021-06-24
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器材摘要
Omnilux CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Globalmed Technologies. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K210948. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Omnilux CLEAR?
Omnilux CLEAR is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Globalmed Technologies. The 510(k) number is K210948.
When did Omnilux CLEAR receive FDA 510(k) clearance?
Omnilux CLEAR received FDA 510(k) clearance on 2021-06-24, under 510(k) number K210948.
Who is the listed applicant for Omnilux CLEAR?
The FDA 510(k) record lists Globalmed Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omnilux CLEAR?
The FDA product code for Omnilux CLEAR is OLP.
相關臨床試驗
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相關器械（代碼：OLP）
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。
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官方來源
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