Instrument, Visual Field, Laser
A Laser Visual Field Instrument is a diagnostic ophthalmic device that uses laser technology to present stimuli for automated visual field testing, enabling precise mapping of the patient's field of vision and detection of scotomas or defects associated with glaucoma, retinal, or neurological conditions. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPJ and is regulated under 21 CFR 886.1360, within the Ophthalmic medical specialty. It is eligible for third-party review.
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Basic Information
- Product Code
- HPJ
- Device Class
- FDA class 2
- Regulation Number
- 886.1360
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K864012 | IRAS PERIMETER | Dec 12, 1986 | Substantially Equivalent | Randwal Instrument Co., Inc. |
| K853556 | LASER IRAS | Nov 01, 1985 | Substantially Equivalent | Randwal Instrument Co., Inc. |
| K822415 | THE OCUPLOT D | Sep 07, 1982 | Substantially Equivalent | Coherent Medical Division |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | Jan 22, 1982 | Substantially Equivalent | American Laser Corp. |
| K781507 | RETINOMETER | Nov 15, 1978 | Substantially Equivalent | Coburn Optical Ind., Inc. |