FDA 510(k)

CoolSculpting System

N.º K: K172144 · 2017-11-01

Fecha de decisión2017-11-01

Código de productoOOK

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.