HKK · Telescope, Spectacle, Low-Vision
Ophthalmic · 21 CFR 886.5870 · Class 1
Overview
| Product Code | HKK |
|---|---|
| Device Name | Telescope, Spectacle, Low-Vision |
| Regulation | 21 CFR 886.5870 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.
Classification Rationale
Class I (general controls). 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. The 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 (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870203 | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | Keeler Instruments, Inc. | Feb 12, 1987 | SESE |
| K864594 | DUALENZ LOW VISION EYEWEAR | Global Eye Care, Inc. | Jan 20, 1987 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 1 clearance
- Global Eye Care, Inc. — 1 clearance
