Product code OXW

Device name

Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy

Medical specialty

Unknown

Device class

N

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.

Source

FDA openFDA device classification dataset