HPJ
5 FDA 510(k) clearances · Product code
58 daysmedian time to decision
75 days90th percentile
5clearances measured
FDA profile
- Official device name
- Instrument, Visual Field, Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1360
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IRAS PERIMETER (K864012) | Randwal Instrument Co., Inc. | 1986-12-12 |
| LASER IRAS (K853556) | Randwal Instrument Co., Inc. | 1985-11-01 |
| THE OCUPLOT D (K822415) | Coherent Medical Division | 1982-09-07 |
| LASER PHOTOCOAGULATOR ARGON MED. LASER (K813429) | American Laser Corp. | 1982-01-22 |
| RETINOMETER (K781507) | Coburn Optical Ind., Inc. | 1978-11-15 |
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Every clearance here is in the API, with alerts when new ones post.