510(k) K853812
- Device
- PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
- Applicant
- BIOSAN LABORATORIES, INC.
- 510(k) number
- K853812
- Product code
- HLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-01
- Date received
- 1985-09-12
- Regulation
- 886.1630
- Classification name
- Photostimulator, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN DOWNING
- Address
- 1016 C St. San Rafael CA US 94901 94901
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 2001-05-04 |
| K983983 | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 1999-02-03 |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | 1993-08-24 |
| K914393 | RETINA TESTER | Retina Tester | 1992-03-02 |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | 1991-10-25 |
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | 1988-02-05 |
| K833446 | DOWNING SPECTRAL ILLUMINATOR | Vision Health Technology | 1984-03-12 |
| K832762 | MILLER/NADLER GLARE TESTER | Titmus Optical, Inc. | 1983-09-29 |
| K831231 | LED GOGGLES | Cadwell Laboratories, Inc. | 1983-05-16 |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | Cadwell Laboratories, Inc. | 1983-04-28 |
| K822922 | 5011 GANZFELD STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 |
| K822919 | 5010 VISUSTIM | Life-Tech Intl., Inc. | 1982-12-28 |
| K822915 | 5031 BRIGHT FLASH STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | Nicolet Biomedical Instruments | 1981-11-16 |
| K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Visidyne Corp. | 1981-06-09 |
Legacy Summary#
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FDA Review#
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