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Home » Electrosurgical Device Classified as Class II
Electrosurgical Device Classified as Class II
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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.
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