GOLDLENS(TM)
Device Facts
| Record ID | K913239 |
|---|---|
| Device Name | GOLDLENS(TM) |
| Applicant | Doran Instruments, Inc. |
| Product Code | HLZ · Ophthalmic |
| Decision Date | Jan 31, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1220 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).
