FDA takes action against Lipo Ex
Its less than 2 months ago that we contacted FDA in order to figure out if Lipo Ex is cleared for “fat reduction” or “weight loss” and their answer was definitely negative! Now FDA with a warning letter underlines false claims and forces RevecoMED to take prompt action in order to correct the violations or else regulatory action (including civil money penalties, injuction etc) may be taken! Here is a part of the letter FDA sent to RevecoMED:
We note that your firm was aware of and approved marketing materials used by your distributor, Advanced Aesthetic Concepts, LLC (AAC) that included the following indications for use of your device:
• Increase Blood Profusion
• Washing out of tissue exudates
• Increased cell membrane permeability
• Increased tissue elasticity
• Increased tissue oxygenation
• Accelerated macrophage and granulocyte activity
• Increased ATP
These materials market the Lipo-Ex program, which includes your device as a component. In addition to the claims specific to your device, these materials make claims about the Lipo-Ex system, including fat reduction claims, comparisons of Lipo-Ex to surgical procedures, and several “before” and “after” photographs showing weight loss.
Approval or clearance is required before the device may be marketed for the above-referenced indications for use.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly connect these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.