OTL — Femtosecond Laser System For Refractive Correction Class III

FDA Device Classification

FDA product code OTL covers "Femtosecond Laser System For Refractive Correction", a Class III medical device. Submissions are reviewed by the Unknown panel.

Classification Details

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

Definition

Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea