21 CFR 886.4355 — Corneal Inlay Inserter Handle
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4355
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QGJ | Corneal Inlay Inserter Handle | 1 | 0 |
