# El.En S.P.A.

- Location (FDA's records): Calenzano, IT
- FDA decisions: 15 (2014–2026): 15 510(k) clearances
- Product codes: GEX (9), ONF (2), NGX (1), IPF (1), PBX (1), PKT (1)
- 510(k) review time since 2016: median 45 days, against 90 for FDA's reviews in the same codes and years (9 of 14 faster)
- Predicates its devices cite: 22 (1 its own); citations of its devices by later devices: 6 (1 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: 8 (https://510kreport.com/company/el-en-electronic-engineering)
- Quanta System Spa: 3 (https://510kreport.com/company/quanta-system)
- Pollogen, Ltd.: 2 (https://510kreport.com/company/pollogen)
- Asclepion Laser Technologies GmbH: 2 (https://510kreport.com/company/asclepion-laser-technologies)
- Cynosure, Inc.: 2 (https://510kreport.com/company/cynosure)
- A.R.C Laser GmbH: 1 (https://510kreport.com/company/arc-laser)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)
- Laseroptek Co., Ltd.: 1 (https://510kreport.com/company/laseroptek)

## Firms that cite its devices most
- Shanghai Apolo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Cynosure, Inc. Dba Ellman: 1 (https://510kreport.com/company/cynosure-dba-ellman)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Solar LS Cjsc: 1 (https://510kreport.com/company/solar-ls-cjsc)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)

## Its most-cited devices
- K133895: Deka Smartxide Laser System (2014), cited by 3
- K233090: DEKA AGAIN PRO family (2023), cited by 2
- K233473: Deka Lotus (2024), cited by 1

## Recent decisions
- K260647: Specchio (Apr 2, 2026)
- K251432: Olo (Aug 6, 2025)
- K243683: Deka Bluebeam (Jun 12, 2025)
- K250281: Deka Lotus (Feb 26, 2025)
- K241459: MOTUS PRO Family (Jun 21, 2024)
- K240752: Deka Toro (May 16, 2024)
- K233473: Deka Lotus (May 16, 2024)
- K234057: Nirvana (Apr 10, 2024)

Source page: https://510kreport.com/company/el-en