HLE — Ruler, Nearpoint (Punctometer) Class I

FDA Device Classification

FDA product code HLE covers "Ruler, Nearpoint (Punctometer)", a Class I medical device regulated under 21 CFR 886.1790. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code
HLE
Device Class
Class I
Regulation Number
886.1790
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No