HPG
7 FDA 510(k) clearances · Product code
86 daysmedian time to decision
114 days90th percentile
7clearances measured
FDA profile
- Official device name
- Aid, Vision, Electronic, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5900
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PATHFINDER (K910601) | Nurion Industries | 1991-05-14 |
| LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124) | Triangle Investments | 1991-04-10 |
| LASER CANE (K903558) | Nurion Industries | 1990-09-27 |
| POLARON (K902187) | Nurion Industries | 1990-08-08 |
| SENSORY 6 (K862338) | Brytech, Inc. | 1986-09-03 |
| ALES (K823385) | Oms | 1983-03-09 |
| F4912 NIGHT VISION AID (K761215) | Itt Corp. | 1976-12-16 |
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Every clearance here is in the API, with alerts when new ones post.