FDA 510(k)

Zionic 美容设备

K号: K230659 · 2023-06-08

决定日期2023-06-08

产品代码PBX

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

Zionic Aesthetic is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K230659. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zionic Aesthetic?

Zionic Aesthetic is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Termosalud. The 510(k) number is K230659.

When did Zionic Aesthetic receive FDA 510(k) clearance?

Zionic Aesthetic received FDA 510(k) clearance on 2023-06-08, under 510(k) number K230659.

Who is the listed applicant for Zionic Aesthetic?

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

What is the FDA product code for Zionic Aesthetic?

The FDA product code for Zionic Aesthetic is PBX.

列明Termosalud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。

K243488VMAT PRO K241656Eneka Selectif K230412Symmed Elite 美容 K223680Eneka Pro

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。