Data / Medical devices / Pupillometer, Ac-Powered
Pupillometer, Ac-Powered (HLG): 25 FDA-registered makers in 9 countries
25 establishments in 9 countries are registered with the FDA to make Pupillometer, Ac-Powered (product code HLG, Class 1, 21 CFR 886.1700). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 2, 1992, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HLG
- Device class
- 1
- Regulation
- 886.1700
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 4 |
| France | 3 |
| Japan | 2 |
| India | 1 |
| Turkey | 1 |
| Canada | 1 |
| Italy | 1 |
| China | 1 |
Makers of Pupillometer, 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 |
|---|---|---|---|---|---|---|---|---|
| Brightlamp, Inc | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Vision GMBH | AALEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnosys LLC | Lowell, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ESSILOR International Usine de la Compasserie | Ligny en Barrois Meuse, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fielmann Group AG | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heru, Inc. | Miami, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idmed | Marseille Bouches-du-Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | 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 | |
| Metrovision SAS | Perenchies Nord, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuroptics, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculera Saglik Teknolojileri A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olleyes, Inc. | Summit, NJ, United States | 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 | |
| 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 | |
| Solvemed Inc. | Lewes, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiyuan North China Xinyuan Tech. Center (Co., LTD.) | TAIYUAN Shaanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Veero Analytics, LLC | Cambridge, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Walmart Inc. | Bentonville, AR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WaveLight GmbH | Teltow Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 2, 1992. 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.