The following data is part of a premarket notification filed by Cosmedico Light, Inc. with the FDA for Ultraviolet Lamps For Tanning.
| Device ID | K935854 |
| 510k Number | K935854 |
| Device Name: | ULTRAVIOLET LAMPS FOR TANNING |
| Classification | Booth, Sun Tan |
| Applicant | COSMEDICO LIGHT, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 -1218 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon COSMEDICO LIGHT, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 -1218 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-08 |
| Decision Date | 1994-01-24 |