Data / Medical devices / United States / Diopsys Inc.
Diopsys Inc.: FDA-registered device maker in Middletown, PA, United States, 1 510(k) clearance
Diopsys Inc. is registered with the FDA (registration 3004174467) in Middletown, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2011. 2 recall events name it as the recalling firm. Registered through 2026. 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.
- FDA registration number
- 3004174467
- Address
- 1000 Kreider Drive STE 700, Middletown, PA, United States, 17057
- Owner or operator
- OpZira, Inc. (10093974)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 27, 2025
- Registered through
- 2026
- Brand names listed
- NOVA ARGOS Vision Testing System, NOVA Vision Testing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Photic, Evoked Response | GWE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2011 | K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | GWE | Substantially Equivalent | Diopsys, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 2, 2007 | 55252 | Not yet classified | Terminated | Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF. | The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007. | accessdata.fda.gov |
| September 15, 2004 | 29999 | Not yet classified | Terminated | The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch f | The firm established no medical device quality system, no established quality plan and no established quality procedures. | accessdata.fda.gov |
Compare with other makers
Updated May 9, 2011. 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.