Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221363

FEI Number

1221363

Entity Name

DIAGNOSYS LLC

City/State/Country

Lowell, MA, US

Establishment Address

55 TECHNOLOGY DR STE 100, Lowell, MA 01851, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIAGNOSYS LLC (Owner Number: 1221363)

Owner / Operator Contact Address

55 Technology Drive, Suite 100, Lowell, MA 01851, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Envoy monitor Profile Espion E3 ColorBurst stimulator ColorFlash stimulator S2 controller LCD monitor ColorDome stimulator DTL Plus Electrode MaculoScope E3 DiagnosysFST Profile DiagnosysFST E3 Dark Adaptometer Profile Dark Adaptometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLT	Preamplifier, Ac-Powered, Ophthalmic	Ophthalmic	Class 2	886.1640	2022-12-05
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2022-12-05
HLZ	Electrode, Corneal	Ophthalmic	Class 2	886.1220	2022-05-23
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2010-02-22
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation	Ophthalmic	Class 1	886.1050	2022-04-20

Official Correspondent

Jeff Farmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIAGNOSYS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221363. Last updated year: 2026. Please use registration number 1221363 when referencing this establishment in official correspondence.