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Kam Yuen Plastic Products Ltd.: FDA-registered device maker in zhongshan Guangdong, China, 5 510(k) clearances

Name: Kam Yuen Plastic Products Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kam Yuen Plastic Products Ltd. is registered with the FDA (registration 3017905264) in zhongshan Guangdong, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 5, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017905264
Address: No.2 Heng Feng Two Road, Pu Jin Industrial Zone, Gang Kou Town, Zhongshan City,Guangdong P.R China, zhongshan Guangdong, China, 528447
Owner or operator: Kam Yuen Plastic Products Ltd. (10086181)
Roles: Manufacturer
First device listed: October 20, 2022
Registered through: 2026
Brand names listed: A-2588Itch Helper,A-908 Neck Care Quirepment,A-907Beauty Facial Veil,A-902V Face Lift Belt, A-905 Smart Mask Device, A-800, A-800-272, A-800B-272, A-800B-180, A-801, A-802, A-805, A-807, A-808 Laser Hair Growth Helmet, A-803, A-804 Laser Hair Growth Comb, IPL HAIR REMOVAL, IPL HAIR REMOVAL A-2788,A-3588,A-2789,A-3988.A-2088,A-3688,3288,A-2088

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	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
April 5, 2023	K230107	Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588	OHT	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.	accessdata.fda.gov
May 26, 2022	K213027	Laser Hair Growth Comb	OAP	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.	accessdata.fda.gov
May 12, 2022	K213025	Laser hair growth helmet	OAP	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.	accessdata.fda.gov
December 2, 2021	K212907	Aimanfun Lumea Comfort, A-2789/A-3588	ONF	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.	accessdata.fda.gov
October 2, 2019	K190820	Aimanfun Lumea Comfort	OHT	Substantially Equivalent	Kam Yuen Plastic Products , Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 5, 2023. 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.