The following data is part of a premarket notification filed by Paul B. Elder Co. with the FDA for Psoralite Series 30,000.
| Device ID | K791116 |
| 510k Number | K791116 |
| Device Name: | PSORALITE SERIES 30,000 |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | PAUL B. ELDER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-15 |
| Decision Date | 1979-09-04 |