Loupe, Diagnostic/surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
10 adverse event reports on file
- OTHER ACCESSORIESJun 7, 2026InjuryUnomedical Devices S.a De C.v3003442380-2026-28194
- OTHER ACCESSORIESMay 23, 2026InjuryUnomedical Devices S.a De C.v3003442380-2026-21352
- OTHER ACCESSORIESMay 23, 2026InjuryUnomedical Devices S.a De C.v3003442380-2026-21808
- INSETNov 20, 2025MalfunctionUnomedical Devices S.a. De C.v.3003442380-2025-16767
- DENTAL LOUPESAug 21, 2025InjuryOrascoptic/metrex Research LlcMW5175093
- DIMENSION 3 LOUPESMay 30, 2014InjuryKerr Corporation3003848022-2014-00004
- EYEMAG LIGHT SUPPLY UNITMar 3, 2014InjuryCarl Zeiss Meditec Ag9615010-2014-00007
- HIRES ELLIPTICAug 29, 2013InjuryMetrex Research, Llc3003848022-2013-00009
- HIRES PLUSDec 18, 2012InjuryKerr Corporation3003848022-2012-00006
- DIMENSION-3 DENTAL LOUPESMay 16, 2007InjuryKerr Corporation3003848022-2007-00001
Event type breakdown
Recalls
3 recall events for this product code
- Orascoptic Surgical AcuityOpen, ClassifiedAug 26, 2025
Orascoptic Superior Visualization
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Z-2440-2025 · View FDA record ↗ - Orascoptic Surgical AcuityOpen, ClassifiedAug 26, 2025
Orascoptic Superior Visualization
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Z-2444-2025 · View FDA record ↗ - Kerr CorporationTerminatedNov 21, 2012
The brand name of the device is Laser Loupes, a dentalloupe
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 work according to specification, but the marking may not permanently adhere to the device.
Z-0414-2013 · View FDA record ↗
Registered firms
60 firms currently registered for this product code
Foshan Cicada Dental Instrument Co., Ltd.
Foshan Guangdong, CN
Shenzhen Rogin Medical Co., Ltd
shenzhen Guangdong, CN
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Sklar Corporation - Warehouse
Salisbury, MD, US
Xenosys Co., Ltd.
Incheon, KR
Atomo Dental, Inc.
Pleasanton, CA, US
Speedway
India Delhi, IN
Five Star Manufacturing, Inc.
NEW BEDFORD, MA, US
Mark Enterprises
Nashik Maharashtra, IN
Nanjing Yanan Special Lighting Factory
Nanjing Jiangsu, CN
Illuco Co, Ltd
Gumpo-si Gyeonggi, KR
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Kirchner & Wilhelm Gmbh + Co.kg
Asperg Baden-Wurttemberg, DE
Microsurgery Instruments, Inc.
Bellaire, TX, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Zhejiang Fude Medphotonic Co.,ltd.
Huzhou City Zhejiang, CN
Bothwin (beijing) Medical Technology Co., Ltd.
Beijng Beijing, CN
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Medipia Co., Ltd.
Daegu, KR
Song Young Intl. Co.
TAIPEI, TW
Nanchang Micare Medical Equipment Co.,ltd
Nanchang Jiangxi, CN
Enova Illumination, Inc
Minneapolis, MN, US
Elmed, Inc.
Glendale Heights, IL, US
510(k) clearances
4 clearances for this product code