QGJ · Corneal Inlay Inserter Handle
Ophthalmic · 21 CFR 886.4355 · Class 1
Overview
| Product Code | QGJ |
|---|---|
| Device Name | Corneal Inlay Inserter Handle |
| Regulation | 21 CFR 886.4355 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (0)
No cleared devices on record.
