# K151905: 3400E series; E5400 series; E6400 series; Sundazzler series

- Pathway: 510(k) (Traditional)
- Applicant: Heartland Tanning, Inc.
- Decided: Mar 1, 2016 after 232 days
- Product code: LEJ (Booth, Sun Tan)
- Device class: 2
- Regulation: 21 CFR 878.4635
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This sunlamp product is intended exclusively for cosmetic tanning of the human skin.

Source page: https://510kreport.com/device/K151905
Methodology: https://510kreport.com/methodology