HJI
8 FDA 510(k) clearances · Product code
74 daysmedian time to decision
117 days90th percentile
8clearances measured
FDA profile
- Official device name
- Lens, Fundus, Hruby, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1395
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1999: 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 |
|---|---|---|
| BYRNE EXPULSIVE LENS (K923670) | Ocular Instruments, Inc. | 1992-11-16 |
| 60 FUNDUS CAMERA CF-60UV (K901839) | Canon USA, Inc. | 1990-07-05 |
| STRIPE PROJECTOR (K902138) | Academic Catalyst Corp. | 1990-07-05 |
| LASER IMAGING WORK STATION (K897186) | Innovision Medical, Inc. | 1990-03-12 |
| OMS QUARTZ INFUSION CONTACT LENS (K820223) | Optical Micro Systems, Inc. | 1982-02-05 |
| SEBESTYEN IRRIGATING CONTACT LENS (K802927) | Cooper Medical Devices Corp. | 1981-02-05 |
| LANDERS CONTACT LENS (K802971) | Cooper Medical Devices Corp. | 1981-02-05 |
| CHARLES IRRIGATING FUNDUS CONTACT LENS (K760949) | Richard'S Medical Equip., Inc. | 1976-11-11 |
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Every clearance here is in the API, with alerts when new ones post.