Photostimulator, Ac-Powered
FDA product code HLX · Class II (moderate risk) · 21 CFR 886.1630 · Ophthalmic
18510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Life-Tech Intl., Inc. 4
- Cadwell Laboratories, Inc. 2
- Electro-Diagnostic Imaging, Inc. 2
- Potomac Medical System 1
- Visidyne Corp. 1
- Nicolet Biomedical Instruments 1
- Titmus Optical, Inc. 1
- Vision Health Technology 1
- Biosan Laboratories, Inc. 1
- Randwal Instrument Co., Inc. 1
- Lkc Technologies, Inc. 1
- Retina Tester 1
- Clarus Medical Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003442 | Modification to Edi Veris SystemHLX · Traditional | Electro-Diagnostic Imaging, Inc. | 05/04/2001SE |
| K983983 | Edi Veris SystemHLX · Traditional | Electro-Diagnostic Imaging, Inc. | 02/03/1999SE |
| K925741 | Clarus Endoscopic Hook KnifeHLX · Traditional | Clarus Medical Systems, Inc. | 08/24/1993SE |
| K914393 | Retina TesterHLX · Traditional | Retina Tester | 03/02/1992SE |
| K914163 | Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional | Lkc Technologies, Inc. | 10/25/1991SE |
| K873990 | Iras Eds Interferometric StimulatorHLX · Traditional | Randwal Instrument Co., Inc. | 02/05/1988SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | Biosan Laboratories, Inc. | 11/01/1985SE |
| K833446 | Downing Spectral IlluminatorHLX · Traditional | Vision Health Technology | 03/12/1984SE |
| K832762 | Miller/Nadler Glare TesterHLX · Traditional | Titmus Optical, Inc. | 09/29/1983SE |
| K831231 | LED GogglesHLX · Traditional | Cadwell Laboratories, Inc. | 05/16/1983SE |
| K830770 | Contrast Sensitivity EquipmentHLX · Traditional | Cadwell Laboratories, Inc. | 04/28/1983SE |
| K822923 | 5012 Parabolic StimulatorHLX · Traditional | Life-Tech Intl., Inc. | 12/28/1982SE |
| K822922 | 5011 Ganzfeld StimulatorHLX · Traditional | Life-Tech Intl., Inc. | 12/28/1982SE |
| K822919 | 5010 VisustimHLX · Traditional | Life-Tech Intl., Inc. | 12/28/1982SE |
| K822915 | 5031 Bright Flash StimulatorHLX · Traditional | Life-Tech Intl., Inc. | 12/28/1982SE |
| K812331 | VTS-1000 Visual Testing SystemHLX · Traditional | Nicolet Biomedical Instruments | 11/16/1981SE |
| K810699 | Pantops M-2 Electrophysiology SystemHLX · Traditional | Visidyne Corp. | 06/09/1981SE |
| K790637 | Computerized Electro-OculographHLX · Traditional | Potomac Medical System | 08/28/1979SE |