FDA 510(k)

Lucent：強光療法器

K 號：K193072 · 2020-03-05

決定日期2020-03-05

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

Lucent : IPL is the device name listed in this FDA 510(k) record. The listed applicant is Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K193072. 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 Lucent : IPL?

Lucent : IPL is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Luvo Medical Technologies, Inc.. The 510(k) number is K193072.

When did Lucent : IPL receive FDA 510(k) clearance?

Lucent : IPL received FDA 510(k) clearance on 2020-03-05, under 510(k) number K193072.

Who is the listed applicant for Lucent : IPL?

The FDA 510(k) record lists Luvo Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucent : IPL?

The FDA product code for Lucent : IPL is ONF.

其他以 Luvo Medical Technologies, Inc. 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。

K212607達文 K210129RF熱力系統 K203728達文 K193446裸裝：808

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

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