Home › Device types › FSP
Loupe, Diagnostic/Surgical
FDA product code FSP · Class 1 · General, Plastic Surgery
562
Registered devices
10
Adverse events
3
Recalls
4
510(k) clearances
Devices with this code
LOUPE CARRIER SCREW — SONTEC INSTRUMENTS, INC.Orascoptic - Dragonfly EyeZoom Mini — METREX RESEARCH, LLCSTERILIZABLE LEVERS — SONTEC INSTRUMENTS, INC.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Luxe™ 2.5 Semi-custom loupe — METREX RESEARCH, LLCBrasseler USA — Peter Brasseler Holdings, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Brasseler USA — Peter Brasseler Holdings, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.EyeZoom™ Plano - Dragonfly™ — METREX RESEARCH, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Orascoptic - RDH Ergo 3.0 — METREX RESEARCH, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Brasseler USA — Peter Brasseler Holdings, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.ri-derma dermatoscope head LED 3.5 V, — Rudolf Riester GmbHBrasseler USA — Peter Brasseler Holdings, LLCEyeZoom™ Rx - XV1™ — METREX RESEARCH, LLCXHL XENON HALOGEN SPARE BULB — SONTEC INSTRUMENTS, INC.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2025-07-03 | Orascoptic Surgical Acuity | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. |
| 2012-04-10 | Kerr Corporation | The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes wor |
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