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Data / Medical devices / Brush, Dermabrasion, Powered

Brush, Dermabrasion, Powered (GFE): 137 FDA-registered makers in 18 countries

137 establishments in 18 countries are registered with the FDA to make Brush, Dermabrasion, Powered (product code GFE, Class 1, 21 CFR 878.4820). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on December 9, 1996, and lists 0 recall events (0 Class I). 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.

Product code
GFE
Device class
1
Regulation
878.4820
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China64
United States33
South Korea11
Italy4
Israel4
Mexico3
Canada3
Ireland3
Taiwan2
Hong Kong2
Costa Rica1
Poland1
Argentina1
Brazil1
Malaysia1
Latvia1
Netherlands1
Spain1

Makers of Brush, Dermabrasion, Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
360 Aesthetic Devices, LLCNaples, FL, United StatesSpecification developer0000api.fda.gov
Aboel Electronic Technology (shenzhen) Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Advance-Esthetic LLCFort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
AllerganLa Aurora De Heredia, Costa RicaManufacturer0000api.fda.gov
Alleva Medical (D.G.) LtdDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Alleva Medical DevicesPomona, CA, United StatesManufacturer0000api.fda.gov
Amarigo IncLos Angeles, CA, United StatesManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Asterasys Co., Ltd.Seongdong-gu Seoul, South KoreaManufacturer0000api.fda.gov
B&M S.R.L.Milano, ItalyManufacturer0000api.fda.gov
Beijing Adss Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Beijing Beautemax Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Beijing Winkonlaser Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Berger & KraftRASZYN Mazowieckie, PolandManufacturer0000api.fda.gov
BioanaMonterrey Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Bioware Technologies Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Brain Health Spectrum (chengdu) Artificial Intelligence Technology Co., Ltd.Chengdu Sichuan, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Brera Medical IncorporatedNorthborough, MA, United StatesManufacturer0000api.fda.gov
Bestway Plastic And Metal Products Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Changsha Gomecy Electronics Co., Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
CPMT Laser Usa LLCMiami, FL, United StatesManufacturer0000api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Complant Zhejiang Import & Export Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dectronique (1984) Inc. Dba Dectro InternationalQuebec, CanadaManufacturer0000api.fda.gov
Dongguan Define Beauty Electronic Technology Co.,ltdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Miqiang Technology Co., LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Yanxi Technology Co. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Yanxin Technology Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
DRC HealthcareUijeongbu-si Gyeonggi, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Duplex International Trading LimitedHong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Dongguan Yipincheng Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Ecleris SRLVilla Martelli Buenos Aires, ArgentinaManufacturer0000api.fda.gov
Ema Aesthetic LtdDublin Dublin(City), IrelandManufacturer0000api.fda.gov
Eunsung Global Corp.Wonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
Formatk Systems Ltd.Tirat Hacarmel Northern, IsraelManufacturer0000api.fda.gov
Foshan Haiseer Electronic Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Genesis Biosystems Inc.Lewisville, TX, United StatesManufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
Glownar Aesthetics. LLCDavie, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Guangdong Xinbao Electrical Appliances Holdings Co.,ltdFoshan Guangdong, ChinaContract manufacturer0000api.fda.gov
Guangzhou Huaju Information Technology Co., Ltdguangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Konmison Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Niansheng Beauty Equipment Co., Ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangdong Newdermo Biotech Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Titan Smart Electrical Appliance Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Haidari Beauty Technology (beijing) Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Hangzhou Yunchi Technology Co., LtdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Hatch Product Development LLCWauconda, IL, United StatesContract manufacturer0000api.fda.gov
Healux Co.,ltdGeumcheon-gu, Seoul, South KoreaManufacturer0000api.fda.gov
Heat In A Click LLCDania, FL, United StatesSpecification developer0000api.fda.gov
Heifeng Zhizao(shenzhen)technology Co.,ltdshenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Hi Tech Electronic Manufacturing CorporationOceanside, CA, United StatesContract manufacturer0000api.fda.gov
Hironic Co., Ltd.Yongin-Si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Hong Qiangxing (shen Zhen) Electronics LimitedShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hong Yu Kang Technology (guangdong) Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
HSC Co., Ltd.Yongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Huizhou Hizorion Tech Co.,ltdHuizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hironic Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
HydraFacial LLCLong Beach, CA, United StatesManufacturer0000api.fda.gov
I. ShermanAcre Northern, IsraelContract manufacturer, Manufacturer0000api.fda.gov
Ids LtdPaju Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ibramed Industria Brasileira de Equipamentos Medicos LtdaAmparo Sao Paulo, BrazilManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jean Marie Lorenz S.R.L.San Mango Piemonte Campania, ItalyManufacturer0000api.fda.gov
Jet Tech Europe S.R.L.Milan Milano, ItalyExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
King Ultrasonic Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Kmi Imi Group / Dba: Innovative Med, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Lifeline Medical, Inc.Mount Dora, FL, United StatesManufacturer0000api.fda.gov
Luvo Medical Technologies, Inc.Cambridge Ontario, CanadaManufacturer0000api.fda.gov
Mattioli Engineering Italia SRLCalenzano Firenze, ItalySpecification developer0000api.fda.gov
META SYSTEMS CO., LTD also doing business as S-Denti Co.,LtdSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA CellmyxCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Neauvia North America, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ningbo Raffini Import & Export Co., LtdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ninghai Sunshine Commodity Co.,ltdNINGHAI,NINGBO Zhejiang, ChinaManufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Ofan Intelligent Technology (guangzhou) Co. Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Ojan Beauty Company LimitedGuangzhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Pollogen LtdTel Aviv, IsraelManufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Procell Therapies, LLCAustin, TX, United StatesManufacturer0000api.fda.gov
Plexus Manufacturing Sdn.Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Raja Trading Company, Inc.Fairfax, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Rejuva Fresh LLCShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Rejuvatek Medical, IncSandy, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Shandong Huamei Technology Co.,ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov
Shanghai May Skin Information Technology Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Balinda Technology Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Baolijie Technology Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Jie Bishi Technology Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Joose Beauty Electronic Co.,ltdShen Zhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Shenzhen Perfect Idea Technology LimitedShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Shengbanghua Technology Development Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Shuge Medical Beauty Devices Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yiguangnian Innovation Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sia SuperboostRIGA Stopinu Novads, LatviaManufacturer0000api.fda.gov
Silhouet-Tone CorporationLAVAL Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Silk'n Beauty Ltd.Rotterdam Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Skinrex Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Svenson Network Holdings LimitedHK Hong Kong, ChinaManufacturer0000api.fda.gov
Shandong Moonlight Electronics Tech Co.,Ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov
Shenzhen Bway Tech Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Jie Zhong Lian Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Margotan Tech Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Meijiante Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Weijie Intelligent Technology Company Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Shenzhen Xiazhifeng Electronic Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer0000api.fda.gov
Tavtech, Ltd.YEHUD Central, IsraelManufacturer0000api.fda.gov
Termosalud S.L.Gijon Asturias(Autonomous Community), SpainManufacturer0000api.fda.gov
TG3 ElectronicsKenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tohkai Precision International Ltd.Kwun Tong, Kowloon, Hong KongManufacturer0000api.fda.gov
Touchbeauty Beauty & Health (shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Vis (shanghai) Technology Co., Ltd.Jinshan District Shanghai, ChinaManufacturer0000api.fda.gov
WEERO Co., Ltd.Suwon-si,Gyeonggi-do, South KoreaManufacturer0000api.fda.gov
Wuhan Qolight Technology Co., Ltd.Wuhan Hubei, ChinaManufacturer0000api.fda.gov
Weifang Dragonfly Electronic Technology Co., Ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov
Xiamen Solex High-Tech Industries Co.,ltdXiamen Fujian, ChinaContract manufacturer0000api.fda.gov
XOD IncPhiladelphia, PA, United StatesSpecification developer0000api.fda.gov
Xsonx, LLCCharlotte, NC, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Yabeikang Technology (dongguan) Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Yiwu VIFA Imp.&Exp. Co., LTDYiwu Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zeltiq Aesthetics Inc.Dublin, CA, United StatesManufacturer0000api.fda.gov
Zeltiq Aesthetics, Inc.Pleasanton, CA, United StatesSpecification developer0000api.fda.gov
Zeltiq Aesthetics, Inc.Livermore, CA, United StatesManufacturer0000api.fda.gov
Zhejiang Beauty And Health Electrical Appliance Co., Ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Pusu Electric Appliance Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhongshan Kingdom Electrical Appliance Co., Ltd.Zhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Meiyigou Electronics Co.,ltdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zeltiq Aesthetics IncDublin, CA, United StatesManufacturer0000api.fda.gov
Zhongshan BestClean Technology Co.,Ltdzhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Bisen Plastic Electronic Products Co.,LtdZhongshan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated December 9, 1996. 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.