The following data is part of a premarket notification filed by Ultralite with the FDA for Spectra305.
| Device ID | K820492 |
| 510k Number | K820492 |
| Device Name: | SPECTRA305 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | ULTRALITE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-23 |
| Decision Date | 1982-03-31 |