FDA 510(k)

好萊塢SPECTRA雷射系統

K 號：K213569 · 2022-02-04

決定日期2022-02-04

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

HOLLYWOOD SPECTRA Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213569. 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 HOLLYWOOD SPECTRA Laser System?

HOLLYWOOD SPECTRA Laser System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Lutronic Corporation. The 510(k) number is K213569.

When did HOLLYWOOD SPECTRA Laser System receive FDA 510(k) clearance?

HOLLYWOOD SPECTRA Laser System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213569.

Who is the listed applicant for HOLLYWOOD SPECTRA Laser System?

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

What is the FDA product code for HOLLYWOOD SPECTRA Laser System?

The FDA product code for HOLLYWOOD SPECTRA Laser System is GEX. This falls under the Gastroenterology category.

其他以 Lutronic Corporation 為申請人之記錄

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