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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

CountryMakers
Japan9
United States8
Germany7
China4
Italy2
India2
United Kingdom1
South Korea1
Taiwan1
Switzerland1
France1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Carl Zeiss Meditec AG (jena)JENA Thuringia, GermanySpecification developer10August 24, 2018000api.fda.gov
Carl Zeiss Meditec AG (Jena)Jena Thuringia, GermanyManufacturer9May 31, 2017030api.fda.gov
Reichert Inc.Depew, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4October 6, 2017000api.fda.gov
Topcon Corp.Tokyo, JapanSpecification developer4September 18, 2026000api.fda.gov
Keeler Ltd.WINDSOR, BERKSHIRE Windsor and Maidenhead, United KingdomManufacturer3September 10, 2015000api.fda.gov
Takagi Seiko Co., Ltd.NAKANO-SHI Nagano, JapanExporter to the US, Manufacturer3April 14, 2017000api.fda.gov
66 Vision Tech Co., Ltd.Suzhou Jiangsu, ChinaManufacturer2May 9, 2014000api.fda.gov
Carl Zeiss Vision GMBHAALEN Baden-Wurttemberg, GermanyComplaint file establishment, Exporter to the US, Specification developer2March 18, 2026000api.fda.gov
Huvitz Co., Ltd.Anyang-si Gyeonggi, South KoreaContract manufacturer, Manufacturer2December 3, 2009000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer2February 21, 1990000api.fda.gov
Kowa Co. Ltd. ChofuChofu Tokyo, JapanManufacturer2November 21, 2022000api.fda.gov
Medimaging Integrated Solution Inc.Hsinchu Hsinchu(City), TaiwanContract manufacturer, Exporter to the US, Manufacturer2January 14, 2020000api.fda.gov
VISIA imaging S.r.l.San Giovanni Valdarno Arezzo, ItalyManufacturer2October 5, 2016000api.fda.gov
Appasamy Associates Private Limited ( Ambattur)Chennai Tamil Nadu, IndiaManufacturer1July 31, 2008000api.fda.gov
C.S.O. S.R.L.Scandicci Firenze, ItalyManufacturer1November 9, 1999000api.fda.gov
CARL ZEISS MEDITEC AG (Munich)Muenchen Bavaria, GermanyManufacturer1September 9, 2014000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer1February 23, 2017000api.fda.gov
Chongqing Kanghua Ruiming S&T Co., Ltd.Chongqing, ChinaContract manufacturer, Exporter to the US, Manufacturer1December 21, 2017000api.fda.gov
Chongqing Sunkingdom Medical Instrument Co.,ltdChongqing, ChinaManufacturer1November 22, 2018000api.fda.gov
Haag-Streit AGKOENIZ Bern, SwitzerlandManufacturer1October 20, 2009000api.fda.gov
Hai Laboratories, Inc.Lexington, MA, United StatesManufacturer, Repackager or relabeler1December 4, 2003000api.fda.gov
Luneau Technology OperationsPont-de-l'Arche Eure, FranceManufacturer1July 31, 2008000api.fda.gov
Nidek Co., Ltd.Gamagori, Aichi, JapanSpecification developer1June 11, 2014000api.fda.gov
Nidek Co., Ltd. Hamacho PlantGamagori, Aichi, JapanManufacturer1June 11, 2014000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer1June 11, 2014010api.fda.gov
Right MFG. Co., Ltd.Itabashi-Ku Tokyo, JapanManufacturer1August 30, 2011000api.fda.gov
Shanghai Mediworks Precision Instruments Co., Ltd.Shanghai, ChinaManufacturer1May 11, 2016000api.fda.gov
Carl Zeiss Meditec IncDublin, CA, United StatesManufacturer0010api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Labotech Microscopes India Private LimitedAMBALA CANTT Haryana, IndiaContract manufacturer0000api.fda.gov
Oculus Optikgerate GMBHWETZLAR Hesse, GermanyManufacturer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
TearScience, Inc.Milpitas, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Topcon Healthcare, Inc.Oakland, NJ, United StatesManufacturer for export0000api.fda.gov
Topcon Yamagata Co., LTDYamagata-KEN, JapanContract manufacturer0000api.fda.gov
santec OIS CorporationKomaki Aichi, JapanManufacturer0000api.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.