The FDA announced it will soon reclassify "powered surgical instrument for improvement in the appearance of cellulite" to Class II, meaning those devices would only need a 510(k) for approval.
They were previously classified as a Class III devices requiring a PMA approval because they were not "substantially equivalent" to another commercially available device before the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. All such devices are automatically classified as Class III unless a firm successfully appeals to the FDA to issue a downgrade.
In this case, the change was prompted by Cabochon Aesthetics, which asked the agency to recognize its Cabochon System as a Class II device. The FDA agreed and granted it de novo approval in July 2013, according to the Regulatory Professional Affairs Society. But until the reclassification order, other devices similar to the Cabochon System will still be subject to Class III regulations--designed for high risk devices. Class II regulations are for low to moderate risk devices.
The FDA has described the Cabochon System as "a powered surgical instrument for improvement in the appearance of cellulite... The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples."
The impending final order means that soon other devices deemed substantially equivalent to the Cabochon System will also get 510(k) approval. Look for the order in the Federal Register. The devices will still be subject to special controls, but not the lengthy clinical trials required for PMAs. The special controls include biocompatibility, electrical safety, nonclinical testing and appropriate labeling.
- here's the classification request for Cabochon (PDF)
- and here's more from the RAPS article