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Guangzhou Niansheng Beauty Equipment Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 3 510(k) clearances

Name: Guangzhou Niansheng Beauty Equipment Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Guangzhou Niansheng Beauty Equipment Co., Ltd. is registered with the FDA (registration 3013503862) in Guangzhou Guangdong, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3013503862
Address: Room 201, Building B, Jingsheng Chuangyi Park, Guangzhou Guangdong, China, 510730
Owner or operator: Beijing Niansheng Beauty Technology Co., Ltd. (10085337)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: June 5, 2022
Registered through: 2026
Brand names listed: 0XY-CY19,OXY-T6A,0XY-CY18,0XY-CY17,0XY-CY9A,OXY-CY16,0XY-CY12A,0XY-CY8B,0XY-CY8A,0XY-CY10A,0XY-CY21,, 0XY-CY22,0XY-CY23, OXY-CY24, 0XY-CY25, CO2 Laser Therapy Systems, Co2 Laser device:NS Co2 Laser,LS-X1,NS-O1,LS-X1A,LS-X1B,LS-NS43,LS-NS46,LS-NS47,LS-NS48,NS-O2,NS-O3,NS-O4,NS-O5,, Diode Laser Therapy System, Diode Laser hair removal device:NS Diode Laser, 808 laser hair removal device,NAS-300,NS-Y17,, ELECTRONIC MUSCLE STIMULATOR:NS EMS Muscle massager, Hiemt emslim machine,, EMS4A,EMS4A-1,EMS4A-2,LS-B174B,LS-B174A,NS-B174C,NS-B31A,NS-B31B,NS-B31C,NS-B37,NS-B21,NS-B21A,NS-B22,NS-P5, and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	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
September 17, 2024	K242186	Neo Sculptor (OF-NEO001)	NGX	Substantially Equivalent	Ofan Intelligent Technology (Guangzhou) Co. , Ltd.	accessdata.fda.gov
May 10, 2021	K210168	Diode Laser Therapy Systems	GEX	Substantially Equivalent	Beijing Kes Biology Technology Co., Ltd.	accessdata.fda.gov
June 24, 2020	K193477	Nd: YAG Laser Therapy Systems	GEX	Substantially Equivalent	Beijing Kes Biology Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 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.