El.En Electronic Engineering Spa

Country / region:Italy (IT)

510(k) submissions

Latest clearance

2023-01-04

Product codes

GEX

Cited as predicate

View list →

Product areas

FDA product code distribution

GEX14

510(k) submissions

14 total

K number	Device name	Product code	Class	Decision date
K222221	DEKA HELIX	GEX	Class 2	2023-01-04
K212270	DEKA LipoAI	GEX	Class 2	2021-10-21
K211362	SCAR 3	GEX	Class 2	2021-08-25
K211821	DEKA Motus AZ	GEX	Class 2	2021-07-06
K202258	ERISE Laser handpiece	GEX	Class 2	2021-04-26
K192539	Deka Luxea	GEX	Class 2	2019-12-16
K181867	Deka Smartxide2 Trio	GEX	Class 2	2018-10-02
K181510	ECHOLASER X4	GEX	Class 2	2018-09-04
K181486	DEKA Motus AY	GEX	Class 2	2018-08-30
K180193	DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)	GEX	Class 2	2018-02-21
K172363	DEKA SMARTXIDE ULTRASPEED	GEX	Class 2	2017-11-17
K172362	DEKA SMARTXIDE TOUCH	GEX	Class 2	2017-11-17
K162886	DEKA MOTUS AX	GEX	Class 2	2017-06-19
K150516	DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS	GEX	Class 2	2015-04-13

Company profile

Canonical name: El.En Electronic Engineering Spa
Country: Italy(IT)

Cited predicates

K203441
The Alma Hybrid Laser System
Alma Lasers , Ltd.
K101573
—
—
Not ingested
K133895
—
—
Not ingested
K172362
—
—
Not ingested
K172363
—
—
Not ingested
K181486
—
—
Not ingested
K192539
—
—
Not ingested
K151331
—
—
Not ingested
K180193
—
—
Not ingested
K173002
—
—
Not ingested
K192539
—
—
Not ingested
K142860
—
—
Not ingested
K152714
—
—
Not ingested
K150516
—
—
Not ingested
K103288
—
—
Not ingested
K072564
—
—
Not ingested
K020941
—
—
Not ingested
K112166
—
—
Not ingested
K113504
—
—
Not ingested
K080959
—
—
Not ingested
K150516
—
—
Not ingested
K162886
—
—
Not ingested
K172362
—
—
Not ingested
K081181
—
—
Not ingested
K172362
DEKA SMARTXIDE TOUCH
El.En Electronic Engineering Spa
K081424
—
—
Not ingested
K150516
—
—
Not ingested
K131095
—
—
Not ingested

El.En Electronic Engineering Spa references 28 predicate/reference devices

Cited as predicate

K260632
LASER THERMAL THERAPY KIT
Elesta S.P.A
K241600
Dermablate
Asclepion Laser Technologies GmbH
Not ingested
K241459
MOTUS PRO Family
El.En S.P.A.
Not ingested
K241092
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
Quanta System Spa
K240497
Smartxide Tetra Pro
El.En S.P.A.
Not ingested
K234057
NIRVANA
El.En S.P.A.
Not ingested
K233090
DEKA AGAIN PRO family
El.En S.P.A.
Not ingested
K231309
SCAR 3
El.En Electroinc Engineering Spa
Not ingested
K231309
SCAR 3
El.En Electroinc Engineering Spa
Not ingested
K223540
AvalancheLase Family
Fotona D.O.O.
Not ingested
K213594
ECHOLASER X4
Elesta S.P.A
Not ingested
K212790
XLase Plus
Biotec Italia, Srl
Not ingested
K211821
DEKA Motus AZ
El.En Electronic Engineering Spa
Not ingested
K211821
DEKA Motus AZ
El.En Electronic Engineering Spa
Not ingested
K211821
DEKA Motus AZ
El.En Electronic Engineering Spa
Not ingested
K211821
DEKA Motus AZ
El.En Electronic Engineering Spa
Not ingested
K211362
SCAR 3
El.En Electronic Engineering Spa
Not ingested
K202258
ERISE Laser handpiece
El.En Electronic Engineering Spa
Not ingested
K193426
Elite iQ
Cynosure, LLC
Not ingested
K192539
Deka Luxea
El.En Electronic Engineering Spa
Not ingested
K181486
DEKA Motus AY
El.En Electronic Engineering Spa
Not ingested
K181486
DEKA Motus AY
El.En Electronic Engineering Spa
Not ingested
K180193
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
El.En Electronic Engineering Spa
Not ingested
K172363
DEKA SMARTXIDE ULTRASPEED
El.En Electronic Engineering Spa
K162886
DEKA MOTUS AX
El.En Electronic Engineering Spa
Not ingested
K161632
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
Bios S.R.L.
Not ingested

26 submissions cite El.En Electronic Engineering Spa as a predicate