Zeltiq Coolsculpting System
The device is indicated for cold assisted lipolysis breakdown of fat of the submental area thigh abdomen and flank or love handles in individuals with a body mass index bmi of 30 or less.
Zeltiq coolsculpting system. K151179 p 1 5 zeltiq coolsculpting system 510 k 2. Using technology such as coolsculpting might sound absurd. With the coolsculpting procedure a specially designed cooling applicator is applied to the desired area of fat reduction to extract energy. Zeltiq zeltiq coolsculpting back to search results.
The device is available to physicians specializing in cosmetic procedures. Tingling 2171 event date 11 02 2011. The coolsculpting system is a portable thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. Zeltiq has conducted clinical studies in the submental area thighs abdomen flanks and upper arms.
Device problem appropriate term code not available 3191 patient problems itching sensation 1943. The coolsculpting procedure is fda cleared for the treatment of visible fat bulges in the submental under the chin and submandibular under the jawline areas thigh abdomen and flank along with bra fat back fat underneath the buttocks also known as banana roll and upper arm. Event type no answer provided event description this is concerning the fda approved coolsculpting procedure which is the non invasive. Learn about the coolsculpting cryolipolysis procedure.
It has also been studied with modified treatment parameters mtp. The coolsculpting procedure is fda cleared for the treatment of visible fat bulges in the submental under the chin and submandibular under the jawline areas thigh abdomen and flank along with bra fat back fat underneath the buttocks also known as banana roll and upper arm. The coolsculpting system has not been studied in children or those who are pregnant or lactating. The coolsculpting procedure is fda cleared for the treatment of visible fat bulges in the submental under the chin and submandibular under the jawline areas thigh abdomen and flank along with bra fat back fat underneath the buttocks also known as banana roll and upper arm.
Learn about the coolsculpting cryolipolysis procedure. This treatment often simply referred to as fat freezing has been performed more than 650 000 times worldwide since its first use. Coolsculpting is an procedure that uses patented technology from the company zeltiq. The coolsculpting procedure is fda cleared for the treatment of visible fat bulges in the submental under the chin and submandibular under the jawline areas thigh abdomen and flank along with bra fat back fat underneath the buttocks also known as banana roll and upper arm.
Zeltiq developed an advanced medical device that utilizes cryolipolysis to eliminate fat.