Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

El.En Electronic Engineering Spa — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

121 daysmedian FDA review time
278 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K222221DEKA HELIXEl.En Electronic Engineering Spa2023-01-041630
K213658DEKA SMARTPERIOEl.En Electronic Engineering Spa2022-03-111120
K212270DEKA LipoAIEl.En Electronic Engineering Spa2021-10-21930
K211091Deka Tiac IIEl.En Electronic Engineering Spa2021-10-151860
K211362SCAR 3El.En Electronic Engineering Spa2021-08-251140
K203396DEKA SMARTPERIOEl.En Electronic Engineering Spa2021-08-232780
K211821DEKA Motus AZEl.En Electronic Engineering Spa2021-07-06250
K202258ERISE Laser handpieceEl.En Electronic Engineering Spa2021-04-262590
K202079PhysiqEl.En Electronic Engineering Spa2020-11-251210
K192539Deka LuxeaEl.En Electronic Engineering Spa2019-12-16910
K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa2018-10-02820
K181510ECHOLASER X4El.En Electronic Engineering Spa2018-09-04880
K181486DEKA Motus AYEl.En Electronic Engineering Spa2018-08-30850
K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)El.En Electronic Engineering Spa2018-02-21280
K172363DEKA SMARTXIDE ULTRASPEEDEl.En Electronic Engineering Spa2017-11-171050
K172362DEKA SMARTXIDE TOUCHEl.En Electronic Engineering Spa2017-11-171050
K162886DEKA MOTUS AXEl.En Electronic Engineering Spa2017-06-192450
K150516DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSEl.En Electronic Engineering Spa2015-04-13420
K131095DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMSEl.En Electronic Engineering Spa2013-12-052310
K113504DEKA SMARTXIDE AND DELIVERY ACCESSORIESEl.En Electronic Engineering Spa2013-02-014310
K122125ASA LASER SH1El.En Electronic Engineering Spa2013-01-251910
K103288DEKA SYNCHRO FTEl.En Electronic Engineering Spa2011-01-31840
K101904SMARTXIDE 50 HS/MSEl.En Electronic Engineering Spa2011-01-121880
K082040MINISILK FTEl.En Electronic Engineering Spa2009-08-274050
K082039SYNCHRO HP PLATFORMEl.En Electronic Engineering Spa2009-03-202450
K072159SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNEREl.En Electronic Engineering Spa2007-12-271430
K062762DERMA YAGEl.En Electronic Engineering Spa2007-03-011670

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda