HKT — Prism, Fresnel, Ophthalmic Class I

FDA Device Classification

FDA product code HKT covers "Prism, Fresnel, Ophthalmic", a Class I medical device regulated under 21 CFR 886.1655. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code
HKT
Device Class
Class I
Regulation Number
886.1655
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No