DIAGNOSYS LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1221363	1221363	DIAGNOSYS LLC	1	N	2026-01-01	55 TECHNOLOGY DR STE 100 Lowell MA US 01851

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
30526	1845850458	K913239	GOLDLENS(TM)	HLZ	1992-01-31
30526	2060889582	K863956	MACULOSCOPE(TM)	GWE	1986-11-13
30526	1933087042	K844409	DTL ELECTRODE	HLZ	1985-02-14
30526	1028482916	K221471	E3 and Profile	GWE	2022-11-22
30526	1045581230
30526	1627937097
30526	1814401804

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GWE	2	2022-11-22
HLZ	2	1992-01-31

GUDID#

DTL 2 - A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
DIAGNOSYS LLC
2024-11-11
Espion - Profile is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
DIAGNOSYS LLC
2021-04-26
Espion - E3 is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
DIAGNOSYS LLC
2021-04-26
DTL - A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
DIAGNOSYS LLC
2016-08-29
DTL 2 - A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
DIAGNOSYS LLC
2024-11-11
Standalone - Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
DIAGNOSYS LLC
2023-06-01
ColorDome Desktop Ganzfeld Stimulator - The ColorDome is a flash stimulator component that can only be used as part of the D310 & D315 medical devices.
DIAGNOSYS LLC
2022-12-12
Envoy Mini-OLED - The Envoy Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
2022-12-12
EER Stimulator and Amplifier - The EER is an electrical stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
2022-12-12
ColorFlash Handheld Stimulator - The ColorFlash is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
2022-12-12
LCD Benchtop Assembly w/ Monitor & Fixation Camera - The LCD Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
2022-12-12
ColorBurst Handheld Stimulator - The ColorBurst is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
2022-12-12
Espion - Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
DIAGNOSYS LLC
2021-04-26
Gold Lens - Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).
DIAGNOSYS LLC
2021-04-26
Gold Lens - Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).
DIAGNOSYS LLC
2021-04-26
Espion - Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-5-CDXR-N-N
DIAGNOSYS LLC
2021-04-13
Espion - "Profile System; with 27"" Monitor and 100 Volt power supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-5-27F-N-N"
DIAGNOSYS LLC
2021-04-13
Espion - Profile System; with no stimulator and 110V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-NNNN-N-N
DIAGNOSYS LLC
2021-04-08
Espion - Profile System; with Non-Xenon ColorDome and 220V Power Supply is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-2-CDNS-N-N
DIAGNOSYS LLC
2020-12-02
Espion - E3 System, 110 Volt power supply, ColorDome with Xenon & desktop OR stand (includes long cable), with power supply, and chin rest, Desktop computer & Espion Software is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-CDXRL-NN-N-N-D
DIAGNOSYS LLC
2020-07-28
Espion - E3 System, 110 Volt power supply, Envoy Mini-OLED on a table stand, No computer is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-NNNNN-NN-N-T-N
DIAGNOSYS LLC
2020-04-16
Espion - Profile Gold System; with Xenon ColorDome is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-CDXS-N-N
DIAGNOSYS LLC
2020-03-18
Espion - Profile System; with Xenon ColorDome on an Operating Room Arm; No Power supply, 110V Cart is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-3-CDXR-N-N
DIAGNOSYS LLC
2020-02-11
Espion - E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Software and Accessory Kit is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-3-1-R-1-P
DIAGNOSYS LLC
2020-01-27
Espion - E3 Console 32-Bit Amplifier Amplifier Stand All-in-One Touch Screen Computer with Espion Software and International Accessory Kit is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-3-2-R-4-D
DIAGNOSYS LLC
2019-10-18
Espion - E3 System; with Mini OLED, No computer is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-6-1-N
DIAGNOSYS LLC
2019-09-19
Espion - E3 System; with Mini OLED and Portable computer is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-6-2-P
DIAGNOSYS LLC
2019-09-19
Espion - E3 System; with Xenon ColorDome and Mini OLED with table stand is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-CDXSL-NN-N-T-D
DIAGNOSYS LLC
2016-10-04
Espion - "Cart-only, no control unit, no power unit, with 27"" Monitor is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-N-3-27F-N-N"
DIAGNOSYS LLC
2018-05-30
Espion - "E3 System; with Xenon ColorDome and 27"" Monitor is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-CDXSL-27-N-N-D"
DIAGNOSYS LLC
2019-01-15
Espion - E3 System; with Xenon ColorDome is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D315-1-1-CDXSL-NN-N-N-D
DIAGNOSYS LLC
2016-08-31
Espion - "Profile System; with 27"" Monitor and Mini OLED on extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-B-1-27F-N-X"
DIAGNOSYS LLC
2018-11-14
Espion - Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-G-1-CDXR-1-X
DIAGNOSYS LLC
2018-10-31
Espion - "E3 System; with 23""/27"" Monitor is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configurations:D315-1-1-NNNNN-23-N-N, D315-1-1-NNNNN-27-N-N, D315-1-1-NNNNN-27-N-N-D"
DIAGNOSYS LLC
2016-08-31
Espion - The Profle System with Xenon ColorDome & ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). It's product configuration D310-R-1-CDXS-2-N.
DIAGNOSYS LLC
2016-08-31
Espion - The Profile System; with Non-Xenon ColorDome on an Operating Room Arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-R-1-CDNR-N-N
DIAGNOSYS LLC
2016-08-31
Espion - Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-CDXR-N-N
DIAGNOSYS LLC
2016-08-31
Espion - Profile System; with ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-NNNN-2-N
DIAGNOSYS LLC
2016-08-31
Espion - Profile System; with Non-Xenon ColorDome and ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).Configuration: D310-R-1-CDNS-2-N
DIAGNOSYS LLC
2016-08-31
Espion - Profile System; with Xenon ColorDome and ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-CDXS-2-N
DIAGNOSYS LLC
2016-08-31

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