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FDA 510(k)

Luna二極雷射系統（TL-S20S-TWC，TL-S20S-755A ，TL-S20S-810B）

K 號：K240874 · 2024-05-28

申請人Theralaser Medtech (China) Co., Ltd.
決定日期2024-05-28
產品代碼GEX
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

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is the device name listed in this FDA 510(k) record. The listed applicant is Theralaser Medtech (China) Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K240874. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Theralaser Medtech (China) Co., Ltd.. The 510(k) number is K240874.

When did Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) receive FDA 510(k) clearance?

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) received FDA 510(k) clearance on 2024-05-28, under 510(k) number K240874.

Who is the listed applicant for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

The FDA 510(k) record lists Theralaser Medtech (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

The FDA product code for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is GEX. This falls under the Gastroenterology category.

相關臨床試驗

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