# Ultrasun International B.V.

- Location (FDA's records): Hengelo, NL
- FDA decisions: 1 (2021–2021): 1 510(k) clearance
- Product codes: FTC (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ibl Acquisitions, LLC: 1 (https://510kreport.com/company/ibl-acquisitions)

## Recent decisions
- K210004: i8 Tanning Booth (Dec 10, 2021)

Source page: https://510kreport.com/company/ultrasun-international