Data / Medical devices / Lens, Condensing, Diagnostic
Lens, Condensing, Diagnostic (HJL): 23 FDA-registered makers in 9 countries
23 establishments in 9 countries are registered with the FDA to make Lens, Condensing, Diagnostic (product code HJL, Class 1, 21 CFR 886.1380). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 16, 1979, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HJL
- Device class
- 1
- Regulation
- 886.1380
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 4 |
| India | 4 |
| Taiwan | 2 |
| France | 1 |
| Germany | 1 |
| Japan | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
Makers of Lens, Condensing, 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 |
|---|---|---|---|---|---|---|---|---|
| 66 Vision Tech Co., Ltd. | Suzhou Jiangsu, China | Foreign private label distributor, Manufacturer | 0 | 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 | |
| Fci SAS | BESANCON Doubs, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glaukos Corporation | San Clemente, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heine Optotechnik GMBH & Co. KG. | GILCHING Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ion Vision, Inc. | Campton Hills, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kashmir Surgical Works | AMBALA Haryana, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Randolph, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | LIANYUNGANG Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madhu Instruments Pvt Ltd | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neitz Instruments Company, Ltd. | CHIYODA-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocular Instruments, Inc. | Bellevue, WA, United States | 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 | |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai, China | 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 | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 16, 1979. 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.