Home › Device types › FSP
Loupe, Diagnostic/Surgical
FDA product code FSP · Class 1 · General, Plastic Surgery
586
Registered devices
10
Adverse events
3
Recalls
4
510(k) clearances
Devices with this code
Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Spark TruColor — METREX RESEARCH, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Brasseler USA — Peter Brasseler Holdings, LLCHDL™ 3.0 Rx - XV1™ — METREX RESEARCH, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.HIGH RESOLUTION BINOCULAR LOUPE — SONTEC INSTRUMENTS, INC.Brasseler USA — Peter Brasseler Holdings, LLCBrasseler USA — Peter Brasseler Holdings, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Endeavour MD — METREX RESEARCH, LLCLITHIUM-POLYMER REPLACEMENT BATTERY — SONTEC INSTRUMENTS, INC.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Brasseler USA — Peter Brasseler Holdings, LLCEighteeth — Changzhou Sifary Medical Technology Co., Ltd.LOUPE CARRIER — SONTEC INSTRUMENTS, INC.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Eighteeth — Changzhou Sifary Medical Technology Co., Ltd.Brasseler USA — Peter Brasseler Holdings, LLCOrascoptic - HDL Ergo 3.5 — METREX RESEARCH, LLCSpark TruColor — METREX RESEARCH, LLCHDL™ 3.5 Prism Plano - Dragonfly™ — METREX RESEARCH, LLCOPTIVISOR BINOCULAR MAGINFIER — SONTEC INSTRUMENTS, INC.
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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