The following data is part of a premarket notification filed by Unilam Co., Ltd. with the FDA for Tanning Lamp.
| Device ID | K143043 |
| 510k Number | K143043 |
| Device Name: | Tanning Lamp |
| Classification | Booth, Sun Tan |
| Applicant | UNILAM CO., LTD. 23 SAMDONG-RO, SAMNAM-MYEON, ULJU-GUN, ULSAN Ulsan Gwangyeogsi, KR 689-813 |
| Contact | Youngboo Cho |
| Correspondent | Yang Ho Dong ONBIX CORPORATION #821 SAMIL PLAZA 837-26 YEUKSAM-DONG Gangnam-gu, KR |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2015-04-02 |
| Summary: | summary |