CoolSculpting Elite 系统
K号: K233732 · 2024-09-12
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决定日期2024-09-12
产品代码OOK
咨询委员会SU
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器械摘要
CoolSculpting Elite System is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K233732. 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 CoolSculpting Elite System?
CoolSculpting Elite System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. The 510(k) number is K233732.
When did CoolSculpting Elite System receive FDA 510(k) clearance?
CoolSculpting Elite System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K233732.
Who is the listed applicant for CoolSculpting Elite System?
The FDA 510(k) record lists Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoolSculpting Elite System?
The FDA product code for CoolSculpting Elite System is OOK.
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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。
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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