The following data is part of a premarket notification filed by Ultralite with the FDA for Psoralite.
| Device ID | K761179 |
| 510k Number | K761179 |
| Device Name: | PSORALITE |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | ULTRALITE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-02 |
| Decision Date | 1977-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PSORALITE 73053889 1045343 Dead/Expired |
THOMAS C. ELDER, INC. 1975-06-02 |