HLX — Photostimulator, Ac-Powered Class II
FDA product code HLX covers "Photostimulator, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1630. Submissions are reviewed by the Ophthalmic panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLX
- Device Class
- Class II
- Regulation Number
- 886.1630
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003442 | electro-diagnostic imaging | MODIFICATION TO EDI VERIS SYSTEM | May 4, 2001 |
| K983983 | electro-diagnostic imaging | EDI VERIS SYSTEM | February 3, 1999 |
| K925741 | clarus medical systems | CLARUS ENDOSCOPIC HOOK KNIFE | August 24, 1993 |
| K914393 | retina tester | RETINA TESTER | March 2, 1992 |
| K914163 | lkc technologies | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | October 25, 1991 |
| K873990 | randwal instrument co | IRAS EDS INTERFEROMETRIC STIMULATOR | February 5, 1988 |
| K853812 | biosan laboratories | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | November 1, 1985 |
| K833446 | vision health technology | DOWNING SPECTRAL ILLUMINATOR | March 12, 1984 |
| K832762 | titmus optical | MILLER/NADLER GLARE TESTER | September 29, 1983 |
| K831231 | cadwell laboratories | LED GOGGLES | May 16, 1983 |
| K830770 | cadwell laboratories | CONTRAST SENSITIVITY EQUIPMENT | April 28, 1983 |
| K822915 | life-tech intl | 5031 BRIGHT FLASH STIMULATOR | December 28, 1982 |
| K822922 | life-tech intl | 5011 GANZFELD STIMULATOR | December 28, 1982 |
| K822923 | life-tech intl | 5012 PARABOLIC STIMULATOR | December 28, 1982 |
| K822919 | life-tech intl | 5010 VISUSTIM | December 28, 1982 |
| K812331 | nicolet biomedical instruments | VTS-1000 VISUAL TESTING SYSTEM | November 16, 1981 |
| K810699 | visidyne | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | June 9, 1981 |
| K790637 | potomac medical system | COMPUTERIZED ELECTRO-OCULOGRAPH | August 28, 1979 |