Lightin 系統，Lightin，Lightin 產生器
K 號：K232177 · 2024-07-10
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決定日期2024-07-10
產品代碼SBS
諮詢委員會中文(台灣):
此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：
此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。
公司名稱：[公司名稱]
產品名稱：[產品名稱]
決定相當於
器材摘要
Lightin System, Lightin, Lightin Generator is the device name listed in this FDA 510(k) record. The listed applicant is Solmedix Co., Ltd.. It received FDA 510(k) clearance on 2024-07-10 under 510(k) number K232177. The device is classified under product code SBS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Lightin System, Lightin, Lightin Generator?
Lightin System, Lightin, Lightin Generator is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Solmedix Co., Ltd.. The 510(k) number is K232177.
When did Lightin System, Lightin, Lightin Generator receive FDA 510(k) clearance?
Lightin System, Lightin, Lightin Generator received FDA 510(k) clearance on 2024-07-10, under 510(k) number K232177.
Who is the listed applicant for Lightin System, Lightin, Lightin Generator?
The FDA 510(k) record lists Solmedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lightin System, Lightin, Lightin Generator?
The FDA product code for Lightin System, Lightin, Lightin Generator is SBS.
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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