光醫牙科雷射系統
K 號：K170073 · 2017-07-25
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器材摘要
LightMed Dental Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lightmed Dentaltechnology Corp.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170073. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the LightMed Dental Laser System?
LightMed Dental Laser System is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Lightmed Dentaltechnology Corp.. The 510(k) number is K170073.
When did LightMed Dental Laser System receive FDA 510(k) clearance?
LightMed Dental Laser System received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170073.
Who is the listed applicant for LightMed Dental Laser System?
The FDA 510(k) record lists Lightmed Dentaltechnology Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LightMed Dental Laser System?
The FDA product code for LightMed Dental Laser System is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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。
相關器械（代碼：GEX）
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
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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