FDA 510(k)

CoolSculpting System

K-Nummer: K172144 · 2017-11-01

Entscheidungsdatum2017-11-01

ProduktcodeOOK

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

CoolSculpting System is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K172144. The device is classified under product code OOK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CoolSculpting System?

CoolSculpting System is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Zeltiq Aesthetics. The 510(k) number is K172144.

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

CoolSculpting System received FDA 510(k) clearance on 2017-11-01, under 510(k) number K172144.

Who is the listed applicant for CoolSculpting System?

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

What is the FDA product code for CoolSculpting System?

The FDA product code for CoolSculpting System is OOK.

Zugehörige klinische Studien

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Verwandte Geräte (Code: OOK)

K233732CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics K212707CoolSculpting Elite SystemZeltiq Aesthetics, Inc.K193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K183514ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.

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