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Zhongshan Bisen Plastic Electronic Products Co.,Ltd: FDA-registered device maker in Zhongshan Guangdong, China, 2 510(k) clearances

Name: Zhongshan Bisen Plastic Electronic Products Co.,Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhongshan Bisen Plastic Electronic Products Co.,Ltd is registered with the FDA (registration 3038319732) in Zhongshan Guangdong, China. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 21, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3038319732
Address: 3rd Floor, No. 5 Minyuan Road Torch Development Zone, Zhongshan Guangdong, China, 528437
Owner or operator: Zhongshan Bisen Plastic Electronic Products Co.,Ltd (10093324)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: April 29, 2025
Registered through: 2026
Brand names listed: BZ-0509,BZ-0512,BZ-0155, BZ-3029B, Blackhead Removal BZ-0702D & BZ-0708, Body Fat Analyzer,Body Fat Monitor, Cellulite Massager,Body Sculpting Machine,EXT Spa, HAIR Spa, Massager,BZ-0610,BZ-0633,BZ-0512,BZ-0635,BZ-0609,BZ-3029A, Electric Hair Remover, Eye Massage;Eye Therapy;Face Therapy;Facial Massage;Neck Therapy, Hair Remover and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Grooming	ILW	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Brush, Dermabrasion, Powered	GFE	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cold Pack And Vibrating Massager	PHW	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Manufacturer	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 21, 2021	K212314	IPL Hair Removal Device	OHT	Substantially Equivalent	Zhongshan Bisen Plastic Electronic Products Co., Ltd.	accessdata.fda.gov
January 13, 2017	K162489	RED Light Device	OHS	Substantially Equivalent	Zhongshan Bisen Plastic Electronic Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 21, 2021. 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.