Data / Medical devices / Biomicroscope, Slit-Lamp, Ac-Powered
Biomicroscope, Slit-Lamp, Ac-Powered (HJO): 37 FDA-registered makers in 11 countries
37 establishments in 11 countries are registered with the FDA to make Biomicroscope, Slit-Lamp, Ac-Powered (product code HJO, Class 2, 21 CFR 886.1850). 27 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 109 510(k) clearances under this code, the latest on September 18, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HJO
- Device class
- 2
- Regulation
- 886.1850
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Japan | 9 |
| United States | 8 |
| Germany | 7 |
| China | 4 |
| Italy | 2 |
| India | 2 |
| United Kingdom | 1 |
| South Korea | 1 |
| Taiwan | 1 |
| Switzerland | 1 |
| France | 1 |
Makers of Biomicroscope, Slit-Lamp, Ac-Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carl Zeiss Meditec AG (jena) | JENA Thuringia, Germany | Specification developer | 10 | August 24, 2018 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec AG (Jena) | Jena Thuringia, Germany | Manufacturer | 9 | May 31, 2017 | 0 | 3 | 0 | api.fda.gov |
| Reichert Inc. | Depew, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 4 | October 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Topcon Corp. | Tokyo, Japan | Specification developer | 4 | September 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Keeler Ltd. | WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom | Manufacturer | 3 | September 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Takagi Seiko Co., Ltd. | NAKANO-SHI Nagano, Japan | Exporter to the US, Manufacturer | 3 | April 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| 66 Vision Tech Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 2 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Vision GMBH | AALEN Baden-Wurttemberg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 2 | March 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Huvitz Co., Ltd. | Anyang-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 2 | December 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 2 | February 21, 1990 | 0 | 0 | 0 | api.fda.gov |
| Kowa Co. Ltd. Chofu | Chofu Tokyo, Japan | Manufacturer | 2 | November 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 2 | January 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| VISIA imaging S.r.l. | San Giovanni Valdarno Arezzo, Italy | Manufacturer | 2 | October 5, 2016 | 0 | 0 | 0 | api.fda.gov |
| Appasamy Associates Private Limited ( Ambattur) | Chennai Tamil Nadu, India | Manufacturer | 1 | July 31, 2008 | 0 | 0 | 0 | api.fda.gov |
| C.S.O. S.R.L. | Scandicci Firenze, Italy | Manufacturer | 1 | November 9, 1999 | 0 | 0 | 0 | api.fda.gov |
| CARL ZEISS MEDITEC AG (Munich) | Muenchen Bavaria, Germany | Manufacturer | 1 | September 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 1 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Chongqing Sunkingdom Medical Instrument Co.,ltd | Chongqing, China | Manufacturer | 1 | November 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Haag-Streit AG | KOENIZ Bern, Switzerland | Manufacturer | 1 | October 20, 2009 | 0 | 0 | 0 | api.fda.gov |
| Hai Laboratories, Inc. | Lexington, MA, United States | Manufacturer, Repackager or relabeler | 1 | December 4, 2003 | 0 | 0 | 0 | api.fda.gov |
| Luneau Technology Operations | Pont-de-l'Arche Eure, France | Manufacturer | 1 | July 31, 2008 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 1 | June 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 1 | June 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 1 | June 11, 2014 | 0 | 1 | 0 | api.fda.gov |
| Right MFG. Co., Ltd. | Itabashi-Ku Tokyo, Japan | Manufacturer | 1 | August 30, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai, China | Manufacturer | 1 | May 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec Inc | Dublin, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labotech Microscopes India Private Limited | AMBALA CANTT Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TearScience, Inc. | Milpitas, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Yamagata Co., LTD | Yamagata-KEN, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| santec OIS Corporation | Komaki Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.