FDA 510(k)

Frax 1940用于Nordlys和Frax Pro

K号: K212492 · 2021-12-20

决定日期2021-12-20

产品代码GEX

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决定实质等同

器械摘要

Frax 1940 for Nordlys and Frax Pro is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K212492. 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 Frax 1940 for Nordlys and Frax Pro?

Frax 1940 for Nordlys and Frax Pro is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Candela Corporation. The 510(k) number is K212492.

When did Frax 1940 for Nordlys and Frax Pro receive FDA 510(k) clearance?

Frax 1940 for Nordlys and Frax Pro received FDA 510(k) clearance on 2021-12-20, under 510(k) number K212492.

Who is the listed applicant for Frax 1940 for Nordlys and Frax Pro?

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

What is the FDA product code for Frax 1940 for Nordlys and Frax Pro?

The FDA product code for Frax 1940 for Nordlys and Frax Pro is GEX. This falls under the Gastroenterology category.

列明Candela 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。

K240070Profound Matrix K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)K220853PicoWay 激光系统 K211217Profound Matrix K201111GentleMax Pro Plus K191685PicoWay 激光系统

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官方来源

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