POE — Extended Depth Of Focus Intraocular Lens Class III

FDA Device Classification

FDA product code POE covers "Extended Depth Of Focus Intraocular Lens", a Class III medical device regulated under 21 CFR 886.3600. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants.

Classification Details

Product Code
POE
Device Class
Class III
Regulation Number
886.3600
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Definition

Intended to be implanted to replace the natural lens of an eye.