Corneal Inlay Inserter Handle

QGJ · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4355

Classification

FDA Product Code: QGJ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.4355
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown