The following data is part of a premarket notification filed by Biosan Laboratories, Inc. with the FDA for Photron Neurovisual Stimulator(modification).
| Device ID | K853812 |
| 510k Number | K853812 |
| Device Name: | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) |
| Classification | Photostimulator, Ac-powered |
| Applicant | BIOSAN LABORATORIES, INC. 1016 C ST. San Rafael, CA 94901 |
| Contact | John Downing |
| Correspondent | John Downing BIOSAN LABORATORIES, INC. 1016 C ST. San Rafael, CA 94901 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-12 |
| Decision Date | 1985-11-01 |