zhongshan Bisen plastic electronic products CO, LTD
ChinaFDA applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What zhongshan Bisen plastic electronic products CO, LTD makes
The company manufactures medical devices including a red light therapy device and an intense pulsed light (IPL) hair removal device, designed for therapeutic and cosmetic applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
RED Light Device Ref K162489
Regimes: 510(k) Registry: 510(k)IPL Hair Removal Device Ref K212314
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 527942227
- [email protected]
- Phone
- 1-800-699-9340
FDA establishments
- Zhongshan Bisen Plastic Electronic Products Co., Ltd Zhongshan Guangdong · CN FEI 3038319732
Frequently asked questions
How many devices does zhongshan Bisen plastic electronic products CO, LTD have in the registry?
The registry currently lists 6 devices for zhongshan Bisen plastic electronic products CO, LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list zhongshan Bisen plastic electronic products CO, LTD's devices?
Among its 6 most recently registered devices, zhongshan Bisen plastic electronic products CO, LTD has devices listed in FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do zhongshan Bisen plastic electronic products CO, LTD's devices fall under?
Among its 6 most recently registered devices, the classes recorded for zhongshan Bisen plastic electronic products CO, LTD's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from zhongshan Bisen plastic electronic products CO, LTD in the registry?
The most recently registered devices listed for zhongshan Bisen plastic electronic products CO, LTD include ELEVARE 700 BLACK, ELEVARE 700 PINK, PERFECTIO 850 and PERFECTIO 900.
Which FDA establishments are linked to zhongshan Bisen plastic electronic products CO, LTD?
1 FDA establishment is linked to zhongshan Bisen plastic electronic products CO, LTD in the registry; they are listed on the company page.