FDA 510(k)

皮秒Nd:YAG雷射系統（型號：HS-298）

K 號：K260017 · 2026-04-09

申請人Shanghai Apolo Medical Technology Co., Ltd.

決定日期2026-04-09

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

Picosecond Nd:YAG Laser Systems (Model: HS-298) 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 2026-04-09 under 510(k) number K260017. 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 Picosecond Nd:YAG Laser Systems (Model: HS-298)?

Picosecond Nd:YAG Laser Systems (Model: HS-298) is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K260017.

When did Picosecond Nd:YAG Laser Systems (Model: HS-298) receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser Systems (Model: HS-298) received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260017.

Who is the listed applicant for Picosecond Nd:YAG Laser Systems (Model: HS-298)?

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 Picosecond Nd:YAG Laser Systems (Model: HS-298)?

The FDA product code for Picosecond Nd:YAG Laser Systems (Model: HS-298) is GEX. This falls under the Gastroenterology category.

其他以 Shanghai Apolo Medical Technology Co., Ltd. 為申請人之記錄

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官方來源

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