NUU — Lens, Contact, Orthokeratology, Overnight Class III

FDA Device Classification

FDA product code NUU covers "Lens, Contact, Orthokeratology, Overnight", a Class III medical device regulated under 21 CFR 886.5916. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code
NUU
Device Class
Class III
Regulation Number
886.5916
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

Temporary reduction of myopia or refractive error.