The FDA requires PDO threads to be cleared as a Class II medical device with a 510K certificate and to be packaged properly. FDA approval status is only required for pharmaceuticals like Botox, Class III medical devices etc.
V Soft Lift PDO threads are the first PDO thread to be Class II FDA cleared for the thread inserted in the cannula as a unit. This is preferred over having FDA clearance on the thread alone – for if a practitioner inserts the thread into the cannula on his/her own, the sterilization and/or safety of the unit may be compromised. If a company only has FDA clearance on the thread alone (and not the cannula), it may no longer have FDA clearance when used together as a unit.
There may be companies that advertise that their product is FDA-approved. They are either mistaken, purposefully misleading to make injectors think they are superior, or have no FDA clearance at all. These threads should not be used if there is no 510K certification, as using such threads could jeopardize your license.
The largest PDO and cannula manufacturer in the world
V Soft Lift PDO threads are one of the safest esthetic procedures available. Help your clients achieve skin rejuvenation with quick treatment times and minimal risk. Threads are completely absorbed with very little tissue reaction and no vascular compromise.
Please be aware that you are about to access the international website for V Soft Lift PDO Threads. It’s essential to note that this site has not undergone evaluation by the USA FDA.
The information provided on this platform may discuss regulatory clearances in countries outside the United States. Consequently, it might include indications and uses that extend beyond the FDA-cleared labeling for the product.
It’s important to emphasize that the details presented on this website are not intended to diagnose, treat, cure, or prevent any disease. This information should not be seen as a replacement for advice from a qualified physician or healthcare professional.
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