FDA Product Code
FDA Product Code HLX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1630
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 2001-05-04 | Traditional | PDF ↗ |
| K983983 | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | 1993-08-24 | Traditional | PDF ↗ |
| K914393 | RETINA TESTER | Retina Tester | 1992-03-02 | Traditional | PDF ↗ |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Biosan Laboratories, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K833446 | DOWNING SPECTRAL ILLUMINATOR | Vision Health Technology | 1984-03-12 | Traditional | PDF ↗ |
| K832762 | MILLER/NADLER GLARE TESTER | Titmus Optical, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831231 | LED GOGGLES | Cadwell Laboratories, Inc. | 1983-05-16 | Traditional | PDF ↗ |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | Cadwell Laboratories, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K822922 | 5011 GANZFELD STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K822915 | 5031 BRIGHT FLASH STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K822923 | 5012 PARABOLIC STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K822919 | 5010 VISUSTIM | Life-Tech Intl., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | Nicolet Biomedical Instruments | 1981-11-16 | Traditional | PDF ↗ |
| K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Visidyne Corp. | 1981-06-09 | Traditional | PDF ↗ |
| K790637 | COMPUTERIZED ELECTRO-OCULOGRAPH | Potomac Medical System | 1979-08-28 | Traditional | PDF ↗ |
Product code HLX · Class II · Ophthalmic. Data: openFDA.