FDA 510(k)

MultiCut Solo

K号: K240831 · 2024-11-06

决定日期2024-11-06

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

MultiCut Solo 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 2024-11-06 under 510(k) number K240831. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MultiCut Solo?

MultiCut Solo is a medical device that received FDA 510(k) clearance on 2024-11-06. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K240831.

When did MultiCut Solo receive FDA 510(k) clearance?

MultiCut Solo received FDA 510(k) clearance on 2024-11-06, under 510(k) number K240831.

Who is the listed applicant for MultiCut Solo?

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 MultiCut Solo?

The FDA product code for MultiCut Solo is GCJ.

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 K241600Dermablate K240816MeDioStar K231876MultiPulse HoPLUS K213597MultiCut Solo

查看所有 11 个设备 →

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

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。