The following data is part of a premarket notification filed by G.i.e.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh with the FDA for Ultraviolet Sun Tanning Lamp.
| Device ID | K151674 |
| 510k Number | K151674 |
| Device Name: | Ultraviolet Sun Tanning Lamp |
| Classification | Booth, Sun Tan |
| Applicant | G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH HERZBERGSTRASSE 26 Berlin, DE 10365 |
| Contact | Michael Anders |
| Correspondent | Oliver Eikenberg EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-22 |
| Decision Date | 2015-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14054657500089 | K151674 | 000 |
| 04054657500419 | K151674 | 000 |
| 04054657500372 | K151674 | 000 |
| 04054657500358 | K151674 | 000 |
| 04054657500341 | K151674 | 000 |
| 04054657500327 | K151674 | 000 |
| 04054657500297 | K151674 | 000 |
| 14054657500270 | K151674 | 000 |
| 14054657500256 | K151674 | 000 |
| 54054657600237 | K151674 | 000 |
| 54054657600220 | K151674 | 000 |
| 04054657500198 | K151674 | 000 |
| 04054657500051 | K151674 | 000 |
| 04054657500426 | K151674 | 000 |
| 04054657500464 | K151674 | 000 |
| 14054657500188 | K151674 | 000 |
| 14054657500331 | K151674 | 000 |
| 14054657500041 | K151674 | 000 |
| 14054657500300 | K151674 | 000 |
| 14054657500164 | K151674 | 000 |
| 14054657500287 | K151674 | 000 |
| 14054657500263 | K151674 | 000 |
| 14054657500171 | K151674 | 000 |
| 14054657500522 | K151674 | 000 |
| 14054657500317 | K151674 | 000 |
| 04054657500518 | K151674 | 000 |
| 04054657500501 | K151674 | 000 |
| 04054657500037 | K151674 | 000 |