HLX · Photostimulator, Ac-Powered
Ophthalmic · 21 CFR 886.1630 · Class 2
Overview
| Product Code | HLX |
|---|---|
| Device Name | Photostimulator, Ac-Powered |
| Regulation | 21 CFR 886.1630 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 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 | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | May 4, 2001 | SESE |
| K983983 | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | Feb 3, 1999 | SESE |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | Aug 24, 1993 | SESE |
| K914393 | RETINA TESTER | Retina Tester | Mar 2, 1992 | SESE |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | Oct 25, 1991 | SESE |
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | Feb 5, 1988 | SESE |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Biosan Laboratories, Inc. | Nov 1, 1985 | SESE |
| K833446 | DOWNING SPECTRAL ILLUMINATOR | Vision Health Technology | Mar 12, 1984 | SESE |
| K832762 | MILLER/NADLER GLARE TESTER | Titmus Optical, Inc. | Sep 29, 1983 | SESE |
| K831231 | LED GOGGLES | Cadwell Laboratories, Inc. | May 16, 1983 | SESE |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | Cadwell Laboratories, Inc. | Apr 28, 1983 | SESE |
| K822923 | 5012 PARABOLIC STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| K822922 | 5011 GANZFELD STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| K822919 | 5010 VISUSTIM | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| K822915 | 5031 BRIGHT FLASH STIMULATOR | Life-Tech Intl., Inc. | Dec 28, 1982 | SESE |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | Nicolet Biomedical Instruments | Nov 16, 1981 | SESE |
| K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Visidyne Corp. | Jun 9, 1981 | SESE |
| K790637 | 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
