FDA 510(k)

CoolSculpting Elite 系统

K号: K212707 · 2021-11-05

决定日期2021-11-05

产品代码OOK

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决定实质等同

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.. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212707. 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 2021-11-05. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K212707.

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

CoolSculpting Elite System received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212707.

Who is the listed applicant for CoolSculpting Elite 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 CoolSculpting Elite System?

The FDA product code for CoolSculpting Elite System is OOK.

列明Zeltiq Aesthetics, Inc.为申报人的其他记录

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