§ 886.4570 — Ophthalmic Surgical Marker

(a) 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.

(b) Classification. 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.