臉部輕輕亮醫療設備規範文本 臉LITE
K 號：K191629 · 2019-09-12
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器材摘要
faceLITE is the device name listed in this FDA 510(k) record. The listed applicant is Ismart Marketing Svcs, Ltd.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K191629. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the faceLITE?
faceLITE is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Ismart Marketing Svcs, Ltd.. The 510(k) number is K191629.
When did faceLITE receive FDA 510(k) clearance?
faceLITE received FDA 510(k) clearance on 2019-09-12, under 510(k) number K191629.
Who is the listed applicant for faceLITE?
The FDA 510(k) record lists Ismart Marketing Svcs, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for faceLITE?
The FDA product code for faceLITE is OHS.
相關臨床試驗
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相關器械（代碼：OHS）
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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