PLASTIC OR GLASS MAGNIFIER
Device Facts
| Record ID | K820375 |
|---|---|
| Device Name | PLASTIC OR GLASS MAGNIFIER |
| Applicant | Gazelle Corp. |
| Product Code | HJF · Ophthalmic |
| Decision Date | Jun 14, 1982 |
| 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.
