Data / Medical devices / Low Power Electrosurgical Devices For Skin Lesion Destruction
Low Power Electrosurgical Devices For Skin Lesion Destruction (QVJ): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Low Power Electrosurgical Devices For Skin Lesion Destruction (product code QVJ, Class 2, 21 CFR 878.4400). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on February 20, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QVJ
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Czechia | 1 |
| South Korea | 1 |
| China | 1 |
Makers of Low Power Electrosurgical Devices For Skin Lesion Destruction
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| COMPEX, spol. s r.o. | Brno Mesto Brno, Czechia | Complaint file establishment, Manufacturer, Specification developer | 1 | March 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| GCS Co.,ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Leaflife Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | February 20, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated February 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.