Data / Medical devices / Instrument, Measuring, Stereopsis
Instrument, Measuring, Stereopsis (HLC): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Instrument, Measuring, Stereopsis (product code HLC, Class 1, 21 CFR 886.1460). 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
- HLC
- Device class
- 1
- Regulation
- 886.1460
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 1 |
| Pakistan | 1 |
Makers of Instrument, Measuring, Stereopsis
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 |
|---|---|---|---|---|---|---|---|---|
| 66 Vision Tech Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ama Optics, Inc. | Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Medical Devices, Inc. | Calabasas, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optego Vision USA, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stereo Optical Company LLC | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vision Training Products, Inc. | Mishawaka, IN, United States | Repackager or relabeler, Specification developer | 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.