FDA 510(k)

IPL + 二極雷射機器

K 號：K193328 · 2020-03-25

申請人Beijing Globalipl Development Co., Ltd.

決定日期2020-03-25

產品代碼ONF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

IPL + Diode Laser Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193328. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IPL + Diode Laser Machine?

IPL + Diode Laser Machine is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K193328.

When did IPL + Diode Laser Machine receive FDA 510(k) clearance?

IPL + Diode Laser Machine received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193328.

Who is the listed applicant for IPL + Diode Laser Machine?

The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL + Diode Laser Machine?

The FDA product code for IPL + Diode Laser Machine is ONF.

其他以 Beijing Globalipl Development Co., Ltd. 為申請人之記錄

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。

K222916美國450 二極雷射設備 K220385強烈脈衝光設備 K212611二氧化碳雷射設備

相關器械（代碼：ONF）

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。

K261204強烈脈衝光療法設備Sanhe LEFIS Electronics Co., Ltd.K251545強烈脈衝光療法設備（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952醫療設備名稱：MEDILIGHTMedicreations, LLC K243123IPL治療設備（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA 草莓El.En S.P.A.K242440強烈脈衝光治療系統（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.

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。