HPE · Aid, Vision, Optical, Battery-Powered
Ophthalmic · 21 CFR 886.5915 · Class 1
Overview
| Product Code | HPE |
|---|---|
| Device Name | Aid, Vision, Optical, Battery-Powered |
| Regulation | 21 CFR 886.5915 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.
Classification Rationale
Class I (general controls). The AC-powered device and the battery-powered 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 battery-powered 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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884540 | ETV, ELECTRONIC VISION AID | Sevrain-Tech, Inc. | Jan 19, 1989 | SESE |
Top Applicants
- Sevrain-Tech, Inc. — 1 clearance
