FDA 510(k)

HOLLYWOOD SPECTRA 激光系统

K号: K213569 · 2022-02-04

决定日期2022-02-04

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Lutronic Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251327XERF K244060eCO2 3D K213748CoreLevee K203788DermaV 激光系统 K183566CLARITY II 激光系统 K180945LUTRONIC GENIUS 射频系统

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