ZELTIQ 冷冻溶脂系统
K号: K193566 · 2020-01-21
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决定日期2020-01-21
产品代码OOK
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
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 2020-01-21 under 510(k) number K193566. 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 2020-01-21. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K193566.
When did ZELTIQ CoolSculpting System receive FDA 510(k) clearance?
ZELTIQ CoolSculpting System received FDA 510(k) clearance on 2020-01-21, under 510(k) number K193566.
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.
相关临床试验
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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。
相关器械（代码：OOK）
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。
K233732CoolSculpting Elite 系统Zeltiq Aesthetics, Inc. (Acquired by Allergan AestheticsK212707CoolSculpting Elite 系统Zeltiq Aesthetics, Inc.K183514ZELTIQ 冷冻溶脂系统Zeltiq Aesthetics, Inc.K181740ZELTIQ 冷冻溶脂系统Zeltiq Aesthetics, Inc.K172144CoolSculpting 系统Zeltiq AestheticsK171069ZELTIQ 冷冻溶脂系统Zeltiq Aesthetics, 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。
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