DUALENZ LOW VISION EYEWEAR
Device Facts
| Record ID | K864594 |
|---|---|
| Device Name | DUALENZ LOW VISION EYEWEAR |
| Applicant | Global Eye Care, Inc. |
| Product Code | HKK · Ophthalmic |
| Decision Date | Jan 20, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5870 |
| Device Class | Class 1 |
Regulatory Classification
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.
