FDA product code HPJ: Instrument, Visual Field, Laser
HPJ is the FDA product code for instrument, visual field, laser. It is a Class II device, regulated under 21 CFR 886.1360 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HPJ, from 4 different applicants. The average 510(k) review took 54 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Visual Field, Laser |
| Device class | Class II |
| Regulation | 21 CFR 886.1360 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HPJ clearance
Top HPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Randwal Instrument Co., Inc. | 2 | 1986-12-12 |
| Coherent Medical Division | 1 | 1982-09-07 |
| American Laser Corp. | 1 | 1982-01-22 |
| Coburn Optical Ind., Inc. | 1 | 1978-11-15 |
Most recent HPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864012 | Randwal Instrument Co., Inc. | IRAS PERIMETER | 1986-12-12 | 58 |
| K853556 | Randwal Instrument Co., Inc. | LASER IRAS | 1985-11-01 | 67 |
| K822415 | Coherent Medical Division | THE OCUPLOT D | 1982-09-07 | 27 |
| K813429 | American Laser Corp. | LASER PHOTOCOAGULATOR ARGON MED. LASER | 1982-01-22 | 45 |
| K781507 | Coburn Optical Ind., Inc. | RETINOMETER | 1978-11-15 | 75 |
Recalls for HPJ devices
openFDA lists no recalls for product code HPJ.
Frequently asked questions
What is FDA product code HPJ?
HPJ is the FDA product code for instrument, visual field, laser. It is a Class II device, regulated under 21 CFR 886.1360 and reviewed by the Ophthalmic panel.
What device class is HPJ?
Class II, regulation 21 CFR 886.1360. Typical premarket route: 510(k).
How long does a 510(k) take for product code HPJ?
Across 5 cleared submissions the average was 54 days from receipt to decision (median 58).
Which companies have the most HPJ clearances?
Randwal Instrument Co., Inc. (2); Coherent Medical Division (1); American Laser Corp. (1); Coburn Optical Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPJ
- Run a recall and safety report across every HPJ manufacturer
- Watch product code HPJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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