Are there any other effective or FDA approved cryolipolysis systems like Coolsculpting in USA or any where else? One of my local clinics claims to have cryolipolysis system named as Coolplus or Cyro which is effective and fda approved and made in USA.
March 21, 2018
Answer: FDA approval FDA is a branch of government for the United States , other countries have different governing boards for their approval process of medical devices . Currently Coolsculpting is the only device with fda approval in the United States for cryolipolysis . Coolplas I believe is a device manufactured in China Only CoolSculpting by ZELTIQ is (U.S. Food and Drug Administration 510 (k)-Nr. K090094). Competitive systems claim that because CoolSculpting is FDA-cleared and their devices are based on the CoolSculpting system’s technology, their systems are therefore FDA-cleared. The claim is false. The U.S. Food and Drug Administration does not clear for marketing a technology, it clears for marketing devices. To date, the FDA has cleared only CoolSculpting. In fact, the CoolSculpting system is the only one to have both FDA clearance and a medical CE mark. A device claiming to perform identically to CoolSculpting’s treatments cannot piggy back on ZELTIQ’s FDA clearance without going through the FDA clearance process itself.
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March 21, 2018
Answer: FDA approval FDA is a branch of government for the United States , other countries have different governing boards for their approval process of medical devices . Currently Coolsculpting is the only device with fda approval in the United States for cryolipolysis . Coolplas I believe is a device manufactured in China Only CoolSculpting by ZELTIQ is (U.S. Food and Drug Administration 510 (k)-Nr. K090094). Competitive systems claim that because CoolSculpting is FDA-cleared and their devices are based on the CoolSculpting system’s technology, their systems are therefore FDA-cleared. The claim is false. The U.S. Food and Drug Administration does not clear for marketing a technology, it clears for marketing devices. To date, the FDA has cleared only CoolSculpting. In fact, the CoolSculpting system is the only one to have both FDA clearance and a medical CE mark. A device claiming to perform identically to CoolSculpting’s treatments cannot piggy back on ZELTIQ’s FDA clearance without going through the FDA clearance process itself.
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