FDA Classifies Electrosurgical Device as Class II

FDA is classifying electrosurgical devices for over-the-counter aesthetic use as Class II, special control devices.

Devicemakers submitting a premarket notification for these electrosurgical devices will need to comply with the special controls named in the final order issued on June 29.

These devices are identified as a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

Read the notice here: www.fdanews.com/06-30-16-ClassifyingElectrosurgicalDevice.pdf.