LOW-POWER BINOCULAR LOUPE
Device Facts
| Record ID | K875124 |
|---|---|
| Device Name | LOW-POWER BINOCULAR LOUPE |
| Applicant | Seiler Instrument & Mfg. Co., Inc. |
| Product Code | HOH · Ophthalmic |
| Decision Date | Feb 19, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4770 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.
