El Global Trade, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “El Global Trade, Ltd.” (first 2014, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 118 days, against 90 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 | 2 | 162 |
| 2015 | 0 | — |
| 2016 | 1 | 81 |
| 2017 | 3 | 118 |
| 2018 | 1 | 89 |
| 2019 | 1 | 115 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 208 |
| 2025 | 1 | 101 |
| 2026 | 2 | 298 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name El Global Trade, Ltd. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 6 | 6 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 3 | 3 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 2 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
Review panels
- General and Plastic Surgery (11)
- Neurology (1)
Most recent El Global Trade, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252621 | DeepSkin (DEP100) | NFO | 2026-05-08 | 262 |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | PAY | 2026-01-06 | 334 |
| K250384 | IPL400 | OHT | 2025-05-23 | 101 |
| K232424 | CurrentBody Skin RF | PAY | 2024-03-06 | 208 |
| K183260 | Sensilight Pro / Pistol IPL | OHT | 2019-03-18 | 115 |
| K181095 | RF-Relief | PBX | 2018-07-24 | 89 |
| K172181 | micro IPL | OHT | 2017-10-13 | 86 |
| K170637 | sensiFirm | PBX | 2017-07-14 | 134 |
| K170499 | sensiLift | PAY | 2017-06-15 | 118 |
| K161089 | sensiLight Mini | OHT | 2016-07-08 | 81 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named El Global Trade, Ltd..
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 Global Trade, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “El Global Trade, Ltd.” (first 2014, latest 2026), across 4 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 Global Trade, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name El Global Trade, Ltd. is 126 days. Since 2017: 118 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under El Global Trade, Ltd.?
The most frequent FDA product codes under this applicant name are OHT (Light Based Over-The-Counter Hair Removal, 6); PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, 3); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 2).
Next steps
- See all 12 El Global Trade, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHT, El Global Trade, Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.