LOW VISION ENHANCEMENT SYSTEM (LVES)
Device Facts
| Record ID | K910124 |
|---|---|
| Device Name | LOW VISION ENHANCEMENT SYSTEM (LVES) |
| Applicant | Triangle Investments |
| Product Code | HPG · Ophthalmic |
| Decision Date | Apr 10, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.
