21 CFR 886.1700 — Pupillometer, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1700

Identification

A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

Classification Rationale

Class I (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes