Panels › General, Plastic Surgery › Product code FSP · Class 1
Loupe, Diagnostic/Surgical
Regulation 878.4800
0510(k)s in 12 months (4 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FSP
| Company | 510(k)s | Recalls |
|---|---|---|
| Luxtec Corp. | 2 | 0 |
| Orascoptic Surgical Acuity | 0 | 2 |
| Keeler Instruments, Inc. | 1 | 0 |
| Kerr Corporation | 0 | 1 |
| Zinnanti Surgical Instruments, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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
Custom loupes with Dragonfly frames Open, Classified |
FSP | None listed |
| Nov 21, 2012 | Kerr Corporation The brand name of the device is Laser Loupes, a dentalloupe
with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices.
Laser Loup Terminated |
FSP | None listed |
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