FDA Clears Allergan’s Magnetic Muscle Stimulator
Allergan earned 510(k) marketing clearance for its CoolTone device, a magnetic muscle stimulator used by plastic surgeons for toning the abdominal muscles, buttocks and thighs.
The device uses muscle stimulation to cause involuntary muscle contractions that strengthen the patient’s muscle fibers to improve muscle conditioning.
CoolTone is not for use in the head or heart area, or near metal or electronic implants in the treatment area, like cardiac pacemakers, cochlear implants, intrathecal pumps, implanted defibrillators, implanted neurostimulators, drug pumps, and hearing aids, the company says.
Allergan expects to begin shipping the devices in the fourth quarter of this year.