SURGITEL
Device Facts
| Record ID | K934494 |
|---|---|
| Device Name | SURGITEL |
| Applicant | General Scientific Corp. |
| Product Code | HOH · Ophthalmic |
| Decision Date | Jan 25, 1994 |
| 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.
