# K181455: ProSun sunlamp products, Luxura sunlamp products

- Pathway: 510(k) (Traditional)
- Applicant: Prosun International, LLC
- Decided: Sep 10, 2018 after 98 days
- Product code: LEJ (Booth, Sun Tan)
- Device class: 2
- Regulation: 21 CFR 878.4635
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944015 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944015: Harpo Sunbed, Sun Tanning Machine, Harpo Industries (1994) Summary page 8.

## Recalls of this device
- Dec 10, 2018 · Class II · Z-1177-2019: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
- Dec 10, 2018 · Class II · Z-1176-2019: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

## Indications for use
Tanning Bed Systems are intended to provide tanning of the human skin.

Source page: https://510kreport.com/device/K181455
Methodology: https://510kreport.com/methodology