Data / Medical devices / Prism, Gonioscopic
Prism, Gonioscopic (HKS): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Prism, Gonioscopic (product code HKS, Class 1, 21 CFR 886.1660). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on April 29, 2014, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HKS
- Device class
- 1
- Regulation
- 886.1660
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Taiwan | 2 |
| India | 1 |
| Germany | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
Makers of Prism, Gonioscopic
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 |
|---|---|---|---|---|---|---|---|---|
| Ocular Instruments, Inc. | Bellevue, WA, United States | Manufacturer | 5 | April 1, 1994 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 1 | April 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Specification developer | 1 | April 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteque Corporation I-Lan Factory II | Su-Ao Cheng Yilan, Taiwan | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Surgical Inc | Port St Lucie, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shern Yeong Precise Optical Co., Ltd. | Dongshan Township, Yilan County, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated April 29, 2014. 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.