Panels › Ophthalmic › Product code HLX · Class 2
Photostimulator, Ac-Powered
Regulation 886.1630
0510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HLX
| Company | 510(k)s | Recalls |
|---|---|---|
| Life-Tech Intl., Inc. | 4 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Electro-Diagnostic Imaging, Inc. | 2 | 0 |
| Biosan Laboratories, Inc. | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Lkc Technologies, Inc. | 1 | 0 |
| Nicolet Biomedical Instruments | 1 | 0 |
| Potomac Medical System | 1 | 0 |
| Randwal Instrument Co., Inc. | 1 | 0 |
| Retina Tester | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2001 | K003442 | MODIFICATION TO EDI VERIS SYSTEM Electro-Diagnostic Imaging, Inc. | HLX |
| Feb 3, 1999 | K983983 | EDI VERIS SYSTEM Electro-Diagnostic Imaging, Inc. | HLX |
| Aug 24, 1993 | K925741 | CLARUS ENDOSCOPIC HOOK KNIFE Clarus Medical Systems, Inc. | HLX |
| Mar 2, 1992 | K914393 | RETINA TESTER Retina Tester | HLX |
| Oct 25, 1991 | K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] Lkc Technologies, Inc. | HLX |
| Feb 5, 1988 | K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR Randwal Instrument Co., Inc. | HLX |
| Nov 1, 1985 | K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) Biosan Laboratories, Inc. | HLX |
| Mar 12, 1984 | K833446 | DOWNING SPECTRAL ILLUMINATOR Vision Health Technology | HLX |
| Sep 29, 1983 | K832762 | MILLER/NADLER GLARE TESTER Titmus Optical, Inc. | HLX |
| May 16, 1983 | K831231 | LED GOGGLES Cadwell Laboratories, Inc. | HLX |
| Apr 28, 1983 | K830770 | CONTRAST SENSITIVITY EQUIPMENT Cadwell Laboratories, Inc. | HLX |
| Dec 28, 1982 | K822923 | 5012 PARABOLIC STIMULATOR Life-Tech Intl., Inc. | HLX |
| Dec 28, 1982 | K822922 | 5011 GANZFELD STIMULATOR Life-Tech Intl., Inc. | HLX |
| Dec 28, 1982 | K822919 | 5010 VISUSTIM Life-Tech Intl., Inc. | HLX |
| Dec 28, 1982 | K822915 | 5031 BRIGHT FLASH STIMULATOR Life-Tech Intl., Inc. | HLX |
| Nov 16, 1981 | K812331 | VTS-1000 VISUAL TESTING SYSTEM Nicolet Biomedical Instruments | HLX |
| Jun 9, 1981 | K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM Visidyne Corp. | HLX |
| Aug 28, 1979 | K790637 | COMPUTERIZED ELECTRO-OCULOGRAPH Potomac Medical System | HLX |
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