PANORET, MODEL 1000A
Device Facts
| Record ID | K001111 |
|---|---|
| Device Name | PANORET, MODEL 1000A |
| Applicant | Cmt Medical Technologies, Ltd. |
| Product Code | HKL · Ophthalmic |
| Decision Date | Jul 7, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1780 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
