FDA 510(k)

醫用二極雷射系統（VELAS II-30B、VELAS II-30A、GBOX-15AB、GBOX-20B、CHEESE II-10B）

K 號：K242755 · 2025-05-19

決定日期2025-05-19

產品代碼ILY

諮詢委員會PM

決定相當於

器材摘要

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K242755. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Gigaalaser Company , Ltd.. The 510(k) number is K242755.

When did Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) receive FDA 510(k) clearance?

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) received FDA 510(k) clearance on 2025-05-19, under 510(k) number K242755.

Who is the listed applicant for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

The FDA 510(k) record lists Gigaalaser Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)?

The FDA product code for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) is ILY.

其他以 Gigaalaser Company , Ltd. 為申請人之記錄

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相關器械（代碼：ILY）

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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