HLG · Pupillometer, Ac-Powered
Ophthalmic · 21 CFR 886.1700 · Class 1
Overview
| Product Code | HLG |
|---|---|
| Device Name | Pupillometer, Ac-Powered |
| Regulation | 21 CFR 886.1700 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920937 | COMPUTERIZED PUPIL | Trek Medical Products, Inc. | Oct 2, 1992 | SESE |
| K895609 | PUPIL PATHWAY ANALYZER (PPA) | Pulse Medical Instruments | Nov 2, 1989 | SESE |
| K802351 | F110 PHOTO BINOCULAR OPHTHALMOSCOPE | Minami, Tomine & Lew | Dec 17, 1980 | SESE |
Top Applicants
- Minami, Tomine & Lew — 1 clearance
- Pulse Medical Instruments — 1 clearance
- Trek Medical Products, Inc. — 1 clearance
