HPJ · Instrument, Visual Field, Laser
Ophthalmic · 21 CFR 886.1360 · Class 2
Overview
| Product Code | HPJ |
|---|---|
| Device Name | Instrument, Visual Field, Laser |
| Regulation | 21 CFR 886.1360 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K864012 | IRAS PERIMETER | Randwal Instrument Co., Inc. | Dec 12, 1986 | SESE |
| K853556 | LASER IRAS | Randwal Instrument Co., Inc. | Nov 1, 1985 | SESE |
| K822415 | THE OCUPLOT D | Coherent Medical Division | Sep 7, 1982 | SESE |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | American Laser Corp. | Jan 22, 1982 | SESE |
| K781507 | RETINOMETER | Coburn Optical Ind., Inc. | Nov 15, 1978 | SESE |
Top Applicants
- Randwal Instrument Co., Inc. — 2 clearances
- American Laser Corp. — 1 clearance
- Coburn Optical Ind., Inc. — 1 clearance
- Coherent Medical Division — 1 clearance
