# El.En Electronic Engineering Spa

- Location (FDA's records): Calenzano, IT
- FDA decisions: 27 (2007–2023): 27 510(k) clearances
- Product codes: GEX (21), NVK (2), PBX (1), ONF (1), ILY (1), IPF (1)
- 510(k) review time since 2016: median 105 days, against 90 for FDA's reviews in the same codes and years (5 of 17 faster)
- Predicates its devices cite: 37 (13 its own); citations of its devices by later devices: 36 (13 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
- Lumenis, Inc.: 5 (https://510kreport.com/company/lumenis)
- Cynosure, Inc.: 4 (https://510kreport.com/company/cynosure)
- Quanta System Spa: 3 (https://510kreport.com/company/quanta-system)
- Alma Lasers, Inc.: 3 (https://510kreport.com/company/alma-lasers)
- Candela Corp.: 2 (https://510kreport.com/company/candela)
- El..En. Electroic Engineering Spa: 1 (https://510kreport.com/company/el-en-electroic-engineering)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Millennium Dental Technologies, Inc.: 1 (https://510kreport.com/company/millennium-dental-technologies)

## Firms that cite its devices most
- El.En S.P.A.: 8 (https://510kreport.com/company/el-en)
- Quanta System Spa: 3 (https://510kreport.com/company/quanta-system)
- Elesta S.P.A: 2 (https://510kreport.com/company/elesta)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Clinicon Corp.: 1 (https://510kreport.com/company/clinicon)
- Tentech Co., Ltd.: 1 (https://510kreport.com/company/tentech)
- Biotec Italia, Srl: 1 (https://510kreport.com/company/biotec-italia)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)

## Its most-cited devices
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner (2007), cited by 6
- K150516: Deka Synchro Repla:Y Family of Laser Systems (2015), cited by 6
- K192539: Deka Luxea (2019), cited by 4
- K181510: Echolaser X4 (2018), cited by 2
- K103288: Deka Synchro FT (2011), cited by 2
- K113504: Deka Smartxide and Delivery Accessories (2013), cited by 2

## Recent decisions
- K222221: Deka Helix (Jan 4, 2023)
- K213658: Deka Smartperio (Mar 11, 2022)
- K212270: DEKA LipoAI (Oct 21, 2021)
- K211091: Deka Tiac II (Oct 15, 2021)
- K211362: SCAR 3 (Aug 25, 2021)
- K203396: Deka Smartperio (Aug 23, 2021)
- K211821: DEKA Motus AZ (Jul 6, 2021)
- K202258: ERISE Laser handpiece (Apr 26, 2021)

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