Data / Medical devices / China / Beijing Winkonlaser Technology Limited

Beijing Winkonlaser Technology Limited: FDA-registered device maker in Beijing, China, 6 510(k) clearances

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

Beijing Winkonlaser Technology Limited is registered with the FDA (registration 3015452693) in Beijing, China. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Beijing Winkonlaser Technology Limited

FDA registration number: 3015452693
Address: No.28,Hegezhuang,Xiji Town,Tongzhou Dist., Beijing, China, 101108
Owner or operator: BEIJING WINKONLASER TECHNOLOGY LIMITED (10086148)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: October 18, 2022
Registered through: 2026
Brand names listed: Aqua Facial Hydrogen Oxygen Bubble System, CO2 Fractional Laser System, DT10,DR20,DL500,DL700,DL1000,DL1500,DM40,DM60,DM80,DM90,DM100,DM160,DM180,ML600,CL300,TribuVAI, Diode Laser Hair Removal System, ELECTRONIC MUSCLE STIMULATOR, Elight System; IPL; SHR, Fractional CO2 Laser Therapy System,FC100, FC200, FC300,FC400,FC600,FC700, HIFEM Beauty 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, Exporter to the US, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Exporter to the US, 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
June 12, 2024	K233007	Picosecond Nd:YAG Laser System; PICO LEGEND	GEX	Substantially Equivalent	Ami, Inc.	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
November 30, 2018	K182663	Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System	GEX	Substantially Equivalent	Finemec Co., Ltd.	accessdata.fda.gov
October 27, 2016	K162169	EdgeOne CO2 Laser	GEX	Substantially Equivalent	Jeisys Medical, 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.