§ 886.1040 — Ocular Esthesiometer

(a) Identification. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

(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.