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QGJ — Corneal Inlay Inserter Handle Class I

FDA Device Classification

FDA product code QGJ covers "Corneal Inlay Inserter Handle", a Class I medical device regulated under 21 CFR 886.4355. Submissions are reviewed by the Ophthalmic panel.

Classification Details

Product Code
QGJ
Device Class
Class I
Regulation Number
886.4355
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

FDA data resources