The following data is part of a premarket notification filed by Light Sources, Inc. with the FDA for Fluorescent T12 Uva Tanning Lamp.
| Device ID | K854004 |
| 510k Number | K854004 |
| Device Name: | FLUORESCENT T12 UVA TANNING LAMP |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | LIGHT SOURCES, INC. P.O. BOX 569 410 MAIN ST. Ansonia, CT 06401 |
| Contact | Gene Czako |
| Correspondent | Gene Czako LIGHT SOURCES, INC. P.O. BOX 569 410 MAIN ST. Ansonia, CT 06401 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-10-29 |