QGJ

Corneal Inlay Inserter Handle

Product code: QGJ
Device name: Corneal Inlay Inserter Handle
Device class: Class 1
21 CFR: 21 CFR 886.4355
Medical specialty: Ophthalmic
Marketing pathway: 510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QGJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).