Data / Medical devices / Camera, Ophthalmic, General-Use
Camera, Ophthalmic, General-Use (PJZ): 48 FDA-registered makers in 13 countries
48 establishments in 13 countries are registered with the FDA to make Camera, Ophthalmic, General-Use (product code PJZ, Class 2, 21 CFR 886.1120). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PJZ
- Device class
- 2
- Regulation
- 886.1120
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| China | 12 |
| India | 4 |
| Canada | 3 |
| Italy | 3 |
| Hong Kong | 1 |
| Thailand | 1 |
| Poland | 1 |
| Estonia | 1 |
| Taiwan | 1 |
| Norway | 1 |
| Finland | 1 |
| Brazil | 1 |
Makers of Camera, Ophthalmic, General-Use
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 |
|---|---|---|---|---|---|---|---|---|
| Accutome, Inc. | Malvern, PA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| All Quality & Services, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| All Quality & Services, Inc. | Garland, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BlephEx, LLC | Brentwood, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C-Mer Rainsoptics Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cellview Imaging Inc. | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Bio Newvision Medical Equipment Ltd. | Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing SS Medical Equipments Co., Ltd | Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Sunkingdom Medical Instrument Co.,ltd | Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Airdoc Health Technology Co., Ltd. | Changsha Hunan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Espansione Marketing SPA | FUNO Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Espansione Marketing SPA | CREVALCORE Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrinet Co., Ltd. | Klongluang Pathum Thani, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forus Health PVT.LTD. | Bengaluru Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frey Spolka Jawna | PIASECZNO Mazowieckie, Poland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globe Biomedical Inc | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Ai-Mu Meditec Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Identifeye Health Inc. | Redwood City, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaynes Technology India Limited | Mysore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KYS Vision, Inc. | Elko, NV, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leadway Imaging Inc | La Jolla, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lombart Instrument, Inc. d/b/a Marco Ophthalmic | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Main Meditech Co., Ltd | Chongqing, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medneuroptek Inc. | Johns Creek, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oivi AS | Oslo, Norway | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optomed | Oulu Pohjois-Pohjanmaa, Finland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phelcom Technologies | Sao Carlos Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Technology Group LLC | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remidio Innovative Solutions Private Limited | Bengaluru Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Retivue LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMF Design and Manufacturing Inc. | Mississauga Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SBM Sistemi SRL | Rivalta di Torino, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCOPE HEALTH Inc | New York, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Link Instruments Co.,ltd | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Create Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SR Research Ltd | Oakville Ontario, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VIRTUAL FIELD, Inc | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visuscience Meditech Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.