Data / Medical devices / Lens, Contact, Polymethylmethacrylate, Diagnostic
Lens, Contact, Polymethylmethacrylate, Diagnostic (HJK): 18 FDA-registered makers in 7 countries
18 establishments in 7 countries are registered with the FDA to make Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK, Class 2, 21 CFR 886.1385). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on September 10, 2020, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HJK
- Device class
- 2
- Regulation
- 886.1385
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| France | 2 |
| Taiwan | 2 |
| Netherlands | 1 |
| Mauritius | 1 |
| Switzerland | 1 |
| Mexico | 1 |
Makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
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 | 25 | March 4, 2002 | 0 | 0 | 0 | api.fda.gov |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 4 | August 18, 2015 | 0 | 2 | 0 | api.fda.gov |
| Phakos | Montreuil Seine-Saint-Denis, France | Specification developer | 2 | October 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | ZUIDLAND Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer | 1 | February 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fci SAS | BESANCON Doubs, France | Manufacturer | 1 | February 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Manufacturer | 1 | February 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Haag-Streit AG | KOENIZ Bern, Switzerland | Manufacturer | 1 | June 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Iridex Corporation | San Jose, CA, United States | Manufacturer | 1 | August 6, 1997 | 0 | 0 | 0 | api.fda.gov |
| Iridex Corporation | Mountain View, CA, United States | Manufacturer | 1 | August 6, 1997 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 1 | December 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Specification developer | 1 | December 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Oculus Surgical Inc | Port St Lucie, FL, United States | Manufacturer | 1 | June 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| RxSight Inc. | Aliso Viejo, CA, United States | Manufacturer | 1 | September 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 1 | August 24, 2001 | 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 | |
| Eagle Labs, LLC | Saint Paul, MN, United States | Contract 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 |
Updated September 10, 2020. 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.