Hearing Devices

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

FDA's most stringent device marketing application, required for high-risk Class III devices.

Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.

Software that analyzes medical images to triage, detect, or quantify disease.

Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.

Devices for diagnosing, monitoring, or treating cardiovascular disease.