Company ยท IT
El.En S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 |
| IPF | Stimulator, Muscle, Powered | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K260647 | SPECCHIO El.En S.P.A., IT | PBX |
| Aug 6, 2025 | K251432 | Olo El.En S.P.A., IT | GEX |
| Jun 12, 2025 | K243683 | Deka Bluebeam El.En S.P.A., IT | GEX |
| Feb 26, 2025 | K250281 | DEKA LOTUS El.En S.P.A., IT | ONF |
| Jun 21, 2024 | K241459 | MOTUS PRO Family El.En S.P.A., IT | GEX |
| May 16, 2024 | K240752 | DEKA TORO El.En S.P.A., IT | GEX |
| May 16, 2024 | K233473 | DEKA LOTUS El.En S.P.A., IT | ONF |
| Apr 10, 2024 | K234057 | NIRVANA El.En S.P.A., IT | GEX |
| Mar 20, 2024 | K240537 | SMARTXIDE PRO El.En S.P.A., IT | GEX |
| Mar 12, 2024 | K240497 | Smartxide Tetra Pro El.En S.P.A., IT | GEX |
| Dec 19, 2023 | K233470 | DEKA LILY El.En S.P.A., IT | NGX |
| Oct 27, 2023 | K233090 | DEKA AGAIN PRO family El.En S.P.A., IT | GEX |
| Sep 26, 2023 | K231971 | DEKA PHYSIQ 360 El.En S.P.A., IT | PKT |
| Sep 1, 2023 | K232334 | DEKA SIMON El.En S.P.A., IT | IPF |
| Sep 5, 2014 | K133895 | DEKA SMARTXIDE LASER SYSTEM El.En S.P.A. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||