21 CFR 886.4570 — Marker, Sclera
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4570
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HMQ | Marker, Sclera | 1 | 0 | |
| HMR | Marker, Ocular | 1 | 5 | |
| HRP | Pen, Marking, Surgical | 1 | 0 |
