Lunula雷射
K 號：K153164 · 2016-06-03
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器材摘要
LunulaLaser is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Medical, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K153164. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LunulaLaser?
LunulaLaser is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Erchonia Medical, Inc.. The 510(k) number is K153164.
When did LunulaLaser receive FDA 510(k) clearance?
LunulaLaser received FDA 510(k) clearance on 2016-06-03, under 510(k) number K153164.
Who is the listed applicant for LunulaLaser?
The FDA 510(k) record lists Erchonia Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LunulaLaser?
The FDA product code for LunulaLaser is PDZ.
相關臨床試驗
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相關器械（代碼：PDZ）
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
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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