OXW — Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy Class N

FDA Device Classification

FDA product code OXW covers "Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
OXW
Device Class
Class N
Regulation Number
Submission Type
Review Panel
OP
Medical Specialty
Unknown
Implant
No

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.