OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
Device Facts
| Record ID | K925606 |
|---|---|
| Device Name | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS |
| Applicant | Chiron Vision Corp. |
| Product Code | HMR · Ophthalmic |
| Decision Date | Aug 29, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.
