Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1630](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1630) → HLX — Photostimulator, Ac-Powered

# HLX · Photostimulator, Ac-Powered

_Ophthalmic · 21 CFR 886.1630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX

## Overview

- **Product Code:** HLX
- **Device Name:** Photostimulator, Ac-Powered
- **Regulation:** [21 CFR 886.1630](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1630)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

## Classification Rationale

Class II.

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K003442](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K003442.md) | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | May 4, 2001 | SESE |
| [K983983](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K983983.md) | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | Feb 3, 1999 | SESE |
| [K925741](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K925741.md) | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | Aug 24, 1993 | SESE |
| [K914393](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K914393.md) | RETINA TESTER | Retina Tester | Mar 2, 1992 | SESE |
| [K914163](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K914163.md) | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | Oct 25, 1991 | SESE |
| [K873990](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K873990.md) | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | Feb 5, 1988 | SESE |
| [K853812](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K853812.md) | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Biosan Laboratories, Inc. | Nov 1, 1985 | SESE |
| [K833446](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K833446.md) | DOWNING SPECTRAL ILLUMINATOR | Vision Health Technology | Mar 12, 1984 | SESE |
| [K832762](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K832762.md) | MILLER/NADLER GLARE TESTER | Titmus Optical, Inc. | Sep 29, 1983 | SESE |
| [K831231](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K831231.md) | LED GOGGLES | Cadwell Laboratories, Inc. | May 16, 1983 | SESE |
| [K830770](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K830770.md) | CONTRAST SENSITIVITY EQUIPMENT | Cadwell Laboratories, Inc. | Apr 28, 1983 | SESE |
| [K822923](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K822923.md) | 5012 PARABOLIC STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| [K822922](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K822922.md) | 5011 GANZFELD STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| [K822919](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K822919.md) | 5010 VISUSTIM | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| [K822915](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K822915.md) | 5031 BRIGHT FLASH STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| [K812331](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K812331.md) | VTS-1000 VISUAL TESTING SYSTEM | Nicolet Biomedical Instruments | Nov 16, 1981 | SESE |
| [K810699](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K810699.md) | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Visidyne Corp. | Jun 9, 1981 | SESE |
| [K790637](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K790637.md) | COMPUTERIZED ELECTRO-OCULOGRAPH | Potomac Medical System | Aug 28, 1979 | SESE |

## Top Applicants

- Life-Tech Intl., Inc. — 4 clearances
- Electro-Diagnostic Imaging, Inc. — 2 clearances
- Cadwell Laboratories, Inc. — 2 clearances
- Vision Health Technology — 1 clearance
- Visidyne Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX)

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