El.En S.p.A.
Calenzano, IT
El.En S.P.A. appears in FDA device records in Calenzano, IT. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for El.En S.p.A. between 2023 and 2026. The busiest year on record is 2024, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 4 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260647 | SPECCHIO | PBX | Substantially Equivalent | |
| K251432 | Olo | GEX | Substantially Equivalent | |
| K243683 | Deka Bluebeam | GEX | Substantially Equivalent | |
| K250281 | DEKA LOTUS | ONF | Substantially Equivalent | |
| K241459 | MOTUS PRO Family | GEX | Substantially Equivalent | |
| K240752 | DEKA TORO | GEX | Substantially Equivalent | |
| K233473 | DEKA LOTUS | ONF | Substantially Equivalent | |
| K234057 | NIRVANA | GEX | Substantially Equivalent | |
| K240537 | SMARTXIDE PRO | GEX | Substantially Equivalent | |
| K240497 | Smartxide Tetra Pro | GEX | Substantially Equivalent | |
| K233470 | DEKA LILY | NGX | Substantially Equivalent | |
| K233090 | DEKA AGAIN PRO family | GEX | Substantially Equivalent | |
| K231971 | DEKA PHYSIQ 360 | PKT | Substantially Equivalent | |
| K232334 | DEKA SIMON | IPF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- GEXPowered Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain