Data / Medical devices / China / Beijing Beautemax Technology Limited

Beijing Beautemax Technology Limited: FDA-registered device maker in Beijing, China, 4 510(k) clearances

Name: Beijing Beautemax Technology Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beijing Beautemax Technology Limited is registered with the FDA (registration 3043657394) in Beijing, China. It lists 14 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3043657394
Address: Room 102, No. 89, Yangpo Village, Baoshan Town, Huairou District, Beijing, China, 101400
Owner or operator: Beijing Beautemax Technology Limited (10095045)
Roles: Contract manufacturer, Foreign private label distributor, Manufacturer
First device listed: January 17, 2026
Registered through: 2026
Brand names listed: 980nm Diode Laser Therapy System, Aqua Facial Hydrogen Oxygen Bubble System, CO2 Fractional Laser System, Diode Laser Hair Removal System, ELECTRONIC MUSCLE STIMULATOR, Elight System; IPL; SHR, HIFEM Beauty System, High Intensity Focus Ultrasound (HIFU) System and more

Devices it lists

Device	Product code	Class	Role	Source
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue	PZC	N	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Brush, Dermabrasion, Powered	GFE	1	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Device, Skin Potential Measurement	HCJ	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Gas, Laser Generating	NXF	1	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Laser, Cellulite Appearance	OYW	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Contract manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Contract manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	OUP	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	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
August 13, 2026	K253790	High Intensity Focused Electromagnetic Stimulation Device (FE60)	NGX	Substantially Equivalent	Beijing Winkonlaser Technology Limited	accessdata.fda.gov
September 25, 2024	K241860	Diode Laser Hair Removal System	GEX	Substantially Equivalent	Beijing Winkonlaser Technology Limited	accessdata.fda.gov
July 7, 2022	K221246	IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)	OHT	Substantially Equivalent	Shenzhen Semlamp Intelligent Technology Co., Ltd.	accessdata.fda.gov
July 8, 2008	K081015	CERALAS D 980NM DIODE LASER, MODELS D15 AND D25	GEX	Substantially Equivalent	Biolitec, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 13, 2026. 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.