Data / Medical devices / Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt (PUE): 23 FDA-registered makers in 8 countries
23 establishments in 8 countries are registered with the FDA to make Biomicroscope, Slit-Lamp, Ac-Powered, Exempt (product code PUE, Class 2, 21 CFR 886.1850). 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.
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- Product code
- PUE
- Device class
- 2
- Regulation
- 886.1850
- Medical specialty
- Ophthalmic
Makers by country
Makers of Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
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 |
|---|---|---|---|---|---|---|---|---|
| Apramed USA LLC | Kissimmee, FL, United States | Manufacturer, Repackager or relabeler | 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 | |
| Eyoto Group Limited | Birmingham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frey Spolka Jawna | PIASECZNO Mazowieckie, Poland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gaush Neotech Ltd. | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haag-Streit AG | KOENIZ Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labotech Microscopes India Private Limited | AMBALA CANTT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lightfield Medical, Inc. | Minneapolis, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lightfield Medical Europe, S.L.U. | Viladecans Barcelona, Spain | Manufacturer | 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 | |
| Mark Enterprises | Nashik Maharashtra, India | 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 | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Bolan Optical Electric Co., Ltd | Shanghai, 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 Certainn Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takagi Seiko Co., Ltd. | NAKANO-SHI Nagano, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Towa Medical Instruments Co.,ltd. | Nakano-shi Nagano, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visuscience Meditech Co., Ltd. | WUXI Jiangsu, China | Complaint file establishment, Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 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.