FDA 510(k)

SR-1 皮肤治疗系统

K号: K202884 · 2021-04-13

决定日期2021-04-13

产品代码ONG

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决定实质等同

器械摘要

SR-1 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 2021-04-13 under 510(k) number K202884. 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 SR-1 Skin Treatment System?

SR-1 Skin Treatment System is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is AVAVA, Inc.. The 510(k) number is K202884.

When did SR-1 Skin Treatment System receive FDA 510(k) clearance?

SR-1 Skin Treatment System received FDA 510(k) clearance on 2021-04-13, under 510(k) number K202884.

Who is the listed applicant for SR-1 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 SR-1 Skin Treatment System?

The FDA product code for SR-1 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 K250402AVAVA™ 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

官方来源

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