# K180576: Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)

- Pathway: 510(k) (Traditional)
- Applicant: Lpi, Inc.
- Decided: Apr 19, 2018 after 45 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. The FDA summary names its predicate without a number.
- (no number) ESB –14, 16, 18, 24, and Oasis 36(booth): named in the summary without a submission number
- (no number) Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST (Booth): named in the summary without a submission number
- (no number) Solar Wave 16, 24: named in the summary without a submission number
- (no number) Sunco – 16XS, 24XS, 32XS, and 48Vertical (Booth): named in the summary without a submission number

## Indications for use
The device is intended to be used for the tanning of human skin.

Source page: https://510kreport.com/device/K180576
Methodology: https://510kreport.com/methodology