FDA 510(k)

CoolSculpting Elite System

K-Nummer: K233732 · 2024-09-12

AntragstellerZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics

Entscheidungsdatum2024-09-12

ProduktcodeOOK

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Verwandte Geräte (Code: OOK)

K212707CoolSculpting Elite SystemZeltiq Aesthetics, Inc.K193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K183514ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K172144CoolSculpting SystemZeltiq Aesthetics K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.

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