Data / Medical devices / Aid, Vision Image Intensification
Aid, Vision Image Intensification (HOT): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Aid, Vision Image Intensification (product code HOT, Class 1, 21 CFR 886.5910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 26, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HOT
- Device class
- 1
- Regulation
- 886.5910
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
| India | 1 |
Makers of Aid, Vision Image Intensification
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 |
|---|---|---|---|---|---|---|---|---|
| Acucela Dba Kubota Vision | Seattle, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eschenbach Optik GMBH + Co | Nurnberg Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gentex Corporation | Zeeland, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, 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 |
Updated February 26, 1988. 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.