HKC · Spectacle Microscope, Low-Vision
Ophthalmic · 21 CFR 886.5540 · Class 1
Overview
| Product Code | HKC |
|---|---|
| Device Name | Spectacle Microscope, Low-Vision |
| Regulation | 21 CFR 886.5540 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K830774 | BINOCULAR MAGNIFIER 2X | Almore Intl., Inc. | Apr 6, 1983 | SESE |
Top Applicants
- Almore Intl., Inc. — 1 clearance
