Data / Medical devices / Epilator, High Frequency, Needle-Type
Epilator, High Frequency, Needle-Type (KCW): 17 FDA-registered makers in 8 countries
17 establishments in 8 countries are registered with the FDA to make Epilator, High Frequency, Needle-Type (product code KCW, Class 1, 21 CFR 878.5350). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 43 510(k) clearances under this code, the latest on January 5, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCW
- Device class
- 1
- Regulation
- 878.5350
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 4 |
| Canada | 2 |
| South Korea | 2 |
| United Kingdom | 1 |
| Israel | 1 |
| France | 1 |
| Australia | 1 |
Makers of Epilator, High Frequency, Needle-Type
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 |
|---|---|---|---|---|---|---|---|---|
| Dectronique (1984) Inc. Dba Dectro International | Quebec, Canada | Manufacturer | 1 | January 12, 1995 | 0 | 0 | 0 | api.fda.gov |
| Sterex Electrolysis Intl., Ltd. | Birmingham, United Kingdom | Manufacturer | 1 | October 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| Active Optical Systems, Ltd./Efraim Bidas | PETACH-TIKVA Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agnes Medical Co.,ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aopu Lighting (jinyun) Co., Ltd. | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ballet Technologies LLC. | Hanover, NH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bestway Plastic And Metal Products Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clareblend, Inc. | Reno, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classys Inc | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinity Gold Investment Corp | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instantronics | Durham, NC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Mega SA | BESANCON Doubs, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optego Vision USA, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Permanence Wholesale Pty Ltd | Sydney New South Wales, Australia | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silhouet-Tone Corporation | LAVAL Quebec, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weifang Dragonfly Electronic Technology Co., Ltd. | Weifang Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yongkang Dahua Industry&trade Co.,ltd | yongkang Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 5, 1996. 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.