El.En S.P.A.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “El.En S.P.A.” (first 2014, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 55 days. Since 2017 the median was 44 days, against 99 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 259 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 4 | 43 |
| 2024 | 6 | 44 |
| 2025 | 3 | 90 |
| 2026 | 1 | 34 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name El.En S.P.A. took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 | 9 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 | 1 |
Review panels
Most recent El.En S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260647 | SPECCHIO | PBX | 2026-04-02 | 34 |
| K251432 | Olo | GEX | 2025-08-06 | 90 |
| K243683 | Deka Bluebeam | GEX | 2025-06-12 | 195 |
| K250281 | DEKA LOTUS | ONF | 2025-02-26 | 26 |
| K241459 | MOTUS PRO Family | GEX | 2024-06-21 | 29 |
| K240752 | DEKA TORO | GEX | 2024-05-16 | 58 |
| K233473 | DEKA LOTUS | ONF | 2024-05-16 | 204 |
| K234057 | NIRVANA | GEX | 2024-04-10 | 110 |
| K240537 | SMARTXIDE PRO | GEX | 2024-03-20 | 23 |
| K240497 | Smartxide Tetra Pro | GEX | 2024-03-12 | 21 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named El.En S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under El.En S.P.A.?
FDA lists 15 510(k) clearances under the applicant name “El.En S.P.A.” (first 2014, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by El.En S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name El.En S.P.A. is 55 days. Since 2017: 44 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under El.En S.P.A.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 2); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 15 El.En S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code GEX, El.En S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.