The following data is part of a premarket notification filed by Futuren, Inc. with the FDA for Uv-a Suntanning Equipment 1000-8000.
| Device ID | K834495 |
| 510k Number | K834495 |
| Device Name: | UV-A SUNTANNING EQUIPMENT 1000-8000 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | FUTUREN, INC. 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 | 1983-11-18 |
| Decision Date | 1984-02-06 |