OEL — Laser, Benign Prostatic Hyperplasia Class II

FDA Device Classification

FDA product code OEL covers "Laser, Benign Prostatic Hyperplasia", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
OEL
Device Class
Class II
Regulation Number
878.4810
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia