Product areas
FDA product code distribution
El.En S.P.A.
Country / region:Italy (IT)
510(k) submissions
8
Filtered: GEX
Latest clearance
2025-08-06
Product codes
1
GEX
510(k) submissions
8 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K251432 | Olo | GEX | Class 2 | 2025-08-06 |
| K243683 | Deka Bluebeam | GEX | Class 2 | 2025-06-12 |
| K241459 | MOTUS PRO Family | GEX | Class 2 | 2024-06-21 |
| K240752 | DEKA TORO | GEX | Class 2 | 2024-05-16 |
| K234057 | NIRVANA | GEX | Class 2 | 2024-04-10 |
| K240537 | SMARTXIDE PRO | GEX | Class 2 | 2024-03-20 |
| K240497 | Smartxide Tetra Pro | GEX | Class 2 | 2024-03-12 |
| K233090 | DEKA AGAIN PRO family | GEX | Class 2 | 2023-10-27 |
Company profile
- Canonical name
- El.En S.P.A.
- Country
- Italy(IT)
Cited predicates
12- K133297
—
—
Not ingested - K192272
Wolf445nm
- K211821
DEKA Motus AZ
- K233090
DEKA AGAIN PRO family
- K202503
Chrome
- K213569
HOLLYWOOD SPECTRA Laser System
- K230373
HELIOS 785 Pico
- K072159
—
—
Not ingested - K180193
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
- K192483
MeDioStar
- K192539
Deka Luxea
- K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
El.En S.P.A. references 12 predicate/reference devices