Product areas
FDA product code distribution
El.En Electronic Engineering Spa
Country / region:Italy (IT)
510(k) submissions
14
Filtered: GEX
Latest clearance
2023-01-04
Product codes
1
GEX
510(k) submissions
14 total · filtered by GEX
| 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
28- K203441
The Alma Hybrid Laser System
- K101573
—
—
Not ingested - K133895
—
—
Not ingested - K172362
DEKA SMARTXIDE TOUCH
- K172363
DEKA SMARTXIDE ULTRASPEED
- K181486
DEKA Motus AY
- K192539
Deka Luxea
- K151331
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K180193
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
- K173002
2940 nm Er:Yag Laser Handpiece
- K192539
Deka Luxea
- K142860
Lumenis M22 System
- K152714
Quanta Forte
- K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K103288
—
—
Not ingested - K072564
—
—
Not ingested - K020941
—
—
Not ingested - K112166
—
—
Not ingested - K113504
—
—
Not ingested - K080959
—
—
Not ingested - K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K162886
DEKA MOTUS AX
- K172362
DEKA SMARTXIDE TOUCH
- K081181
—
—
Not ingested - K172362
DEKA SMARTXIDE TOUCH
- K081424
—
—
Not ingested - K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K131095
—
—
Not ingested
El.En Electronic Engineering Spa references 28 predicate/reference devices
Cited as predicate
26- K260632
LASER THERMAL THERAPY KIT
- K241600
Dermablate
- K241459
MOTUS PRO Family
- K241092
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- K240497
Smartxide Tetra Pro
- K234057
NIRVANA
- K233090
DEKA AGAIN PRO family
- K231309
SCAR 3
- K231309
SCAR 3
- K223540
AvalancheLase Family
- K213594
ECHOLASER X4
- K212790
XLase Plus
- K211821
DEKA Motus AZ
- K211821
DEKA Motus AZ
- K211821
DEKA Motus AZ
- K211821
DEKA Motus AZ
- K211362
SCAR 3
- K202258
ERISE Laser handpiece
- K193426
Elite iQ
- K192539
Deka Luxea
- K181486
DEKA Motus AY
- K181486
DEKA Motus AY
- K180193
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
- K172363
DEKA SMARTXIDE ULTRASPEED
- K162886
DEKA MOTUS AX
- K161632
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
26 submissions cite El.En Electronic Engineering Spa as a predicate