FDA 510(k)

ZELTIQ 冷冻溶脂系统

K号: K160259 · 2016-03-23

决定日期2016-03-23

产品代码OOK

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决定实质等同

器械摘要

ZELTIQ CoolSculpting System is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K160259. The device is classified under product code OOK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZELTIQ CoolSculpting System?

ZELTIQ CoolSculpting System is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K160259.

When did ZELTIQ CoolSculpting System receive FDA 510(k) clearance?

ZELTIQ CoolSculpting System received FDA 510(k) clearance on 2016-03-23, under 510(k) number K160259.

Who is the listed applicant for ZELTIQ CoolSculpting System?

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

What is the FDA product code for ZELTIQ CoolSculpting System?

The FDA product code for ZELTIQ CoolSculpting System is OOK.

列明Zeltiq Aesthetics, 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。

K233804Resonic 快速声脉冲装置 K222629Resonic 快速声脉冲装置 K212707CoolSculpting Elite 系统 K193566ZELTIQ 冷冻溶脂系统 K183514ZELTIQ 冷冻溶脂系统 K181740ZELTIQ 冷冻溶脂系统

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官方来源

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