Orascoptic Surgical Acuity
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2445-2025 | Class II | Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 2 | July 3, 2025 |
| Z-2444-2025 | Class II | Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and | July 3, 2025 |
| Z-2440-2025 | Class II | Orascoptic Superior Visualization Custom loupes with Dragonfly frames | July 3, 2025 |
| Z-2443-2025 | Class II | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, s | July 3, 2025 |
| Z-2442-2025 | Class II | Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, | July 3, 2025 |
| Z-2441-2025 | Class II | Orascoptic Superior Visualization Custom loupes configured with Phantom Frames | July 3, 2025 |