FDA 510(k)

皮秒Nd:YAG雷射系統

K 號：K233018 · 2023-12-21

決定日期2023-12-21

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 System is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K233018. 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 System?

PICOSECOND Nd:YAG Laser System is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Ids, Ltd.. The 510(k) number is K233018.

When did PICOSECOND Nd:YAG Laser System receive FDA 510(k) clearance?

PICOSECOND Nd:YAG Laser System received FDA 510(k) clearance on 2023-12-21, under 510(k) number K233018.

Who is the listed applicant for PICOSECOND Nd:YAG Laser System?

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

What is the FDA product code for PICOSECOND Nd:YAG Laser System?

The FDA product code for PICOSECOND Nd:YAG Laser System is GEX. This falls under the Gastroenterology category.

其他以 Ids, Ltd. 為申請人之記錄

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官方來源

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