FDA 510(k)

MCL 31 Dermablate 系统

K号: K210634 · 2022-04-13

决定日期2022-04-13

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

MCL 31 Dermablate System is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K210634. 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 MCL 31 Dermablate System?

MCL 31 Dermablate System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K210634.

When did MCL 31 Dermablate System receive FDA 510(k) clearance?

MCL 31 Dermablate System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210634.

Who is the listed applicant for MCL 31 Dermablate System?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCL 31 Dermablate System?

The FDA product code for MCL 31 Dermablate System is GEX. This falls under the Gastroenterology category.

列明Asclepion Laser Technologies GmbH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。

K261094黄星 K253100MultiPulse TFL K240831MultiCut Solo K241600Dermablate K240816MeDioStar K231876MultiPulse HoPLUS

查看所有 11 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。