FDA 510(k)

強烈脈衝光治療系統（LK-PT）

K 號：K242440 · 2024-11-14

決定日期2024-11-14

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 Treatment System (LK-PT) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K242440. 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 Treatment System (LK-PT)?

Intense Pulsed Light Treatment System (LK-PT) is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K242440.

When did Intense Pulsed Light Treatment System (LK-PT) receive FDA 510(k) clearance?

Intense Pulsed Light Treatment System (LK-PT) received FDA 510(k) clearance on 2024-11-14, under 510(k) number K242440.

Who is the listed applicant for Intense Pulsed Light Treatment System (LK-PT)?

The FDA 510(k) record lists Nanjing Bestview Laser S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intense Pulsed Light Treatment System (LK-PT)?

The FDA product code for Intense Pulsed Light Treatment System (LK-PT) is ONF.

其他以 Nanjing Bestview Laser S&T 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。

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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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