HMR · Marker, Ocular
Ophthalmic · 21 CFR 886.4570 · Class 1
Overview
| Product Code | HMR |
|---|---|
| Device Name | Marker, Ocular |
| Regulation | 21 CFR 886.4570 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Refractec, Inc. | Mar 3, 2006 | SESE |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Chiron Vision Corp. | Aug 29, 1994 | SESE |
| K872747 | LASER CENTERING DEVICE | Innomed Corp. | Sep 4, 1987 | SESE |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Myocure, Inc. | Oct 20, 1986 | SESE |
| K861535 | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | CooperVision, Inc. | May 14, 1986 | SESE |
Top Applicants
- Refractec, Inc. — 1 clearance
- Myocure, Inc. — 1 clearance
- Innomed Corp. — 1 clearance
- CooperVision, Inc. — 1 clearance
- Chiron Vision Corp. — 1 clearance
