E3 and Profile
Diagnosys, LLC
DIAGNOSYS LLC
FDA Registration(s)#
| 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 | 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 | 1814401804 |
Product Codes Associated With Registrations#
PMN#
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.
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).
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).
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.
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.
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).
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.
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.
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.
2022-12-12
ColorFlash Handheld Stimulator - The ColorFlash is a flash stimulator component that can only be used as part of the D310 & D315.
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.
2022-12-12
ColorBurst Handheld Stimulator - The ColorBurst is a flash stimulator component that can only be used as part of the D310 & D315.
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).
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).
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).
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
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"
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
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
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
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
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
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
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
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
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
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
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
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"
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"
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
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"
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
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"
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.
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
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
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
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
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
2016-08-31