Company
Orascoptic Surgical Acuity
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Phantom Nose Pad Accessory Kit ( nose pad and screw)
1 pk. and 20 pk. Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Dragonfly Nose Pad Accessory Kit ( nose pad and screw)
1 pk and 20 pk. Open, Classified |
FSP | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Custom loupes configured with Phantom Frames Open, Classified |
EBA | None listed |
| Aug 26, 2025 | Orascoptic Surgical Acuity Orascoptic Superior Visualization
Custom loupes with Dragonfly frames Open, Classified |
FSP | None listed |