BINOCULAR LOUPE
Device Facts
| Record ID | K830878 |
|---|---|
| Device Name | BINOCULAR LOUPE |
| Applicant | Almore Intl., Inc. |
| Product Code | HJH · Ophthalmic |
| Decision Date | Apr 6, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5120 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
