LASER IRAS
Device Facts
| Record ID | K853556 |
|---|---|
| Device Name | LASER IRAS |
| Applicant | Randwal Instrument Co., Inc. |
| Product Code | HPJ · Ophthalmic |
| Decision Date | Nov 1, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.
