BINOCULAR MAGNIFIER 2X
Device Facts
| Record ID | K830774 |
|---|---|
| Device Name | BINOCULAR MAGNIFIER 2X |
| Applicant | Almore Intl., Inc. |
| Product Code | HKC · Ophthalmic |
| Decision Date | Apr 6, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
