FDA 510(k)

AVAVA™ 皮肤治疗系统

K号: K250402 · 2025-04-14

决定日期2025-04-14

产品代码ONG

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

AVAVA™ Skin Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is AVAVA, Inc.. It received FDA 510(k) clearance on 2025-04-14 under 510(k) number K250402. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AVAVA™ Skin Treatment System?

AVAVA™ Skin Treatment System is a medical device that received FDA 510(k) clearance on 2025-04-14. The listed applicant is AVAVA, Inc.. The 510(k) number is K250402.

When did AVAVA™ Skin Treatment System receive FDA 510(k) clearance?

AVAVA™ Skin Treatment System received FDA 510(k) clearance on 2025-04-14, under 510(k) number K250402.

Who is the listed applicant for AVAVA™ Skin Treatment System?

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

What is the FDA product code for AVAVA™ Skin Treatment System?

The FDA product code for AVAVA™ Skin Treatment System is ONG.

列明AVAVA, Inc.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。

K252155AVAVA™ 皮肤治疗系统 K223871Miria 皮肤治疗系统 K221268SR-1 皮肤治疗系统 K213726PL-1 皮肤治疗系统 K202884SR-1 皮肤治疗系统

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。