El.En Electronic Engineering Spa: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “El.En Electronic Engineering Spa” (first 2007, latest 2023), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 121 days. Since 2017 the median was 105 days, against 98 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 231 |
| 2014 | 0 | — |
| 2015 | 1 | 42 |
| 2016 | 0 | — |
| 2017 | 3 | 105 |
| 2018 | 4 | 84 |
| 2019 | 1 | 91 |
| 2020 | 1 | 121 |
| 2021 | 6 | 150 |
| 2022 | 1 | 112 |
| 2023 | 1 | 163 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name El.En Electronic Engineering Spa took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 21 | 21 |
| NVK | Laser, Dental, Soft Tissue | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
- General and Plastic Surgery (23)
- Dental (2)
- Physical Medicine (2)
Most recent El.En Electronic Engineering Spa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222221 | DEKA HELIX | GEX | 2023-01-04 | 163 |
| K213658 | DEKA SMARTPERIO | NVK | 2022-03-11 | 112 |
| K212270 | DEKA LipoAI | GEX | 2021-10-21 | 93 |
| K211091 | Deka Tiac II | PBX | 2021-10-15 | 186 |
| K211362 | SCAR 3 | GEX | 2021-08-25 | 114 |
| K203396 | DEKA SMARTPERIO | NVK | 2021-08-23 | 278 |
| K211821 | DEKA Motus AZ | GEX | 2021-07-06 | 25 |
| K202258 | ERISE Laser handpiece | GEX | 2021-04-26 | 259 |
| K202079 | Physiq | IPF | 2020-11-25 | 121 |
| K192539 | Deka Luxea | GEX | 2019-12-16 | 91 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named El.En Electronic Engineering Spa.
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 Electronic Engineering Spa?
FDA lists 27 510(k) clearances under the applicant name “El.En Electronic Engineering Spa” (first 2007, latest 2023), across 6 product codes in 3 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 Electronic Engineering Spa?
The median time from FDA receipt to decision across 510(k)s cleared under the name El.En Electronic Engineering Spa is 121 days. Since 2017: 105 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under El.En Electronic Engineering Spa?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 21); NVK (Laser, Dental, Soft Tissue, 2); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 27 El.En Electronic Engineering Spa clearances with predicates and recalls
- Run predicate analysis for product code GEX, El.En Electronic Engineering Spa'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.