Data / Medical devices / United States / Diagnosys LLC
Diagnosys LLC: FDA-registered device maker in Lowell, MA, United States, 4 510(k) clearances
Diagnosys LLC is registered with the FDA (registration 1221363) in Lowell, MA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 22, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221363
- Address
- 55 Technology DR Ste 100, Lowell, MA, United States, 01851
- Owner or operator
- DIAGNOSYS LLC (1221363)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 22, 2010
- Registered through
- 2026
- Brand names listed
- ColorBurst stimulator, ColorDome stimulator, ColorFlash stimulator, D410 Eidolon, DTL Plus Electrode, E3, E3 Dark Adaptometer, E3 DiagnosysFST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | OUM | 1 | Manufacturer | accessdata.fda.gov |
| Digital Visual Acuity Test | QTO | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Corneal | HLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Preamplifier, Ac-Powered, Ophthalmic | HLT | 2 | Manufacturer | accessdata.fda.gov |
| Pupillometer, Ac-Powered | HLG | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 22, 2022 | K221471 | E3 and Profile | GWE | Substantially Equivalent | Diagnosys, LLC | accessdata.fda.gov |
| January 31, 1992 | K913239 | GOLDLENS(TM) | HLZ | Substantially Equivalent | Doran Instruments, Inc. | accessdata.fda.gov |
| November 13, 1986 | K863956 | MACULOSCOPE(TM) | GWE | Substantially Equivalent | Doran Instruments, Inc. | accessdata.fda.gov |
| February 14, 1985 | K844409 | DTL ELECTRODE | HLZ | Substantially Equivalent | Sauquoit Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Corneal
- All makers of Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
- All makers of Stimulator, Photic, Evoked Response
- All makers of Digital Visual Acuity Test
- All makers of Pupillometer, Ac-Powered
Updated November 22, 2022. 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.