Data / Medical devices / Target, Fusion And Stereoscopic
Target, Fusion And Stereoscopic (HLP): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Target, Fusion And Stereoscopic (product code HLP, Class 1, 21 CFR 886.1880). 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 November 8, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HLP
- Device class
- 1
- Regulation
- 886.1880
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| United Kingdom | 1 |
| Switzerland | 1 |
| Costa Rica | 1 |
Makers of Target, Fusion And Stereoscopic
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 |
|---|---|---|---|---|---|---|---|---|
| Gulden Ophthalmics | Elkins Park, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haag-Streit Uk Ltd. | Bishop's Stortford Hertfordshire, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lang-Stereotest AG | Kuesnacht Zurich, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mast Keystone, Inc. | Reno, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SACO Internacional S.A. | Bagaces Guanacaste, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 8, 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.