# Elesta S.P.A

- Location (FDA's records): Calenzano, IT
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Product codes: GEX (4)
- 510(k) review time since 2016: median 80 days, against 90 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 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
- El.En Electronic Engineering Spa: 2 (https://510kreport.com/company/el-en-electronic-engineering)
- Biotex, Inc.: 1 (https://510kreport.com/company/biotex)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)

## Its most-cited devices
- K230460: Laser Thermal Therapy Kit (2023), cited by 1
- K213594: Echolaser X4 (2022), cited by 1

## Recent decisions
- K261964: Echolaser X4 (Aug 19, 2026)
- K260632: Laser Thermal Therapy Kit (Mar 17, 2026)
- K230460: Laser Thermal Therapy Kit (May 22, 2023)
- K213594: Echolaser X4 (May 3, 2022)

Source page: https://510kreport.com/company/elesta