HKL · Retinoscope, Ac-Powered
Ophthalmic · 21 CFR 886.1780 · Class 2
Overview
| Product Code | HKL |
|---|---|
| Device Name | Retinoscope, Ac-Powered |
| Regulation | 21 CFR 886.1780 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.
Classification Rationale
(1) Class II (special controls) for the AC-powered device. 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.(2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is 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.
Special Controls
*Classification.* (1) Class II (special controls) for the AC-powered device. 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.(2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | Jul 7, 2000 | SESE |
| K950789 | STREAK RETINOSCOPE RX-1 | Neitz Instruments Company, Ltd. | Mar 28, 1995 | SESE |
| K950790 | STREAK RETINOSCOPE RX-2 | Neitz Instruments Company, Ltd. | Mar 22, 1995 | SESE |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Keeler Instruments, Inc. | Sep 21, 1989 | SESE |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Koi, Inc. | Dec 2, 1981 | SESE |
| K800238 | MOIRE FRINGE VISOMETER AFTER LOTMAR | Hagg-Streit Service, Inc. | Mar 10, 1980 | SESE |
Top Applicants
- Neitz Instruments Company, Ltd. — 2 clearances
- Cmt Medical Technologies, Ltd. — 1 clearance
- Hagg-Streit Service, Inc. — 1 clearance
- Keeler Instruments, Inc. — 1 clearance
- Koi, Inc. — 1 clearance
