FDA 510(k)

纖維雷射治療系統（HS-232，HS-233）

K 號：K251031 · 2025-07-02

申請人Shanghai Apolo Medical Technology Co., Ltd.

決定日期2025-07-02

產品代碼ONG

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

Fiber Laser Treatment Systems (HS-232,HS-233) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251031. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fiber Laser Treatment Systems (HS-232,HS-233)?

Fiber Laser Treatment Systems (HS-232,HS-233) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K251031.

When did Fiber Laser Treatment Systems (HS-232,HS-233) receive FDA 510(k) clearance?

Fiber Laser Treatment Systems (HS-232,HS-233) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251031.

Who is the listed applicant for Fiber Laser Treatment Systems (HS-232,HS-233)?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiber Laser Treatment Systems (HS-232,HS-233)?

The FDA product code for Fiber Laser Treatment Systems (HS-232,HS-233) is ONG.

其他以 Shanghai Apolo Medical Technology 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：ONG）

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。

K252155AVAVA™ 皮膚治療系統AVAVA, Inc.K244060eCO2 3DLutronic Corporation K250402AVAVA™ 皮膚治療系統AVAVA, Inc.K233550MOSAIC 3D（外科雷射）Lutronic Aesthetic K223871美麗雅皮膚治療系統AVAVA, Inc.K221268SR-1皮膚治療系統AVAVA, Inc.

官方來源

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