HRP · Pen, Marking, Surgical
Ophthalmic · 21 CFR 886.4570 · Class 1
Overview
| Product Code | HRP |
|---|---|
| Device Name | Pen, Marking, Surgical |
| Regulation | 21 CFR 886.4570 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.
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.
