The following data is part of a premarket notification filed by Vision Health Technology with the FDA for Downing Spectral Illuminator.
| Device ID | K833446 |
| 510k Number | K833446 |
| Device Name: | DOWNING SPECTRAL ILLUMINATOR |
| Classification | Photostimulator, Ac-powered |
| Applicant | VISION HEALTH TECHNOLOGY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-05 |
| Decision Date | 1984-03-12 |