FDA 510(k)

強烈脈衝光設備

K 號：K220385 · 2022-08-12

申請人Beijing Globalipl Development Co., Ltd.

決定日期2022-08-12

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

Intense Pulsed Light Equipment 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 2022-08-12 under 510(k) number K220385. 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 Intense Pulsed Light Equipment?

Intense Pulsed Light Equipment is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K220385.

When did Intense Pulsed Light Equipment receive FDA 510(k) clearance?

Intense Pulsed Light Equipment received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220385.

Who is the listed applicant for Intense Pulsed Light Equipment?

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 Intense Pulsed Light Equipment?

The FDA product code for Intense Pulsed Light Equipment is ONF.

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

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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。

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官方來源

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