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Data / Medical devices / Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF): 66 FDA-registered makers in 13 countries

66 establishments in 13 countries are registered with the FDA to make Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (product code ONF, Class 2, 21 CFR 878.4810). 37 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 74 510(k) clearances under this code, the latest on June 12, 2026, 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.

Get every maker of this deviceMakers in ChinaWatch this device
Product code
ONF
Device class
2
Regulation
878.4810
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China29
Israel10
United States9
South Korea6
Italy3
Hong Kong2
Taiwan1
France1
Canada1
United Kingdom1
Mexico1
Netherlands1
Brazil1

Makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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
El.en. Electronic Engineering SPACALENZANO Firenze, ItalyManufacturer3February 26, 2025000api.fda.gov
Venus Concept Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3September 11, 2023000api.fda.gov
Venus Concept Inc.Windham, NH, United StatesComplaint file establishment, Manufacturer, Specification developer3September 11, 2023000api.fda.gov
Alma Lasers Ltd.CAESAREA Northern, IsraelManufacturer2June 13, 2018000api.fda.gov
Beijing Globalipl Development Co., Ltd.Beijing, ChinaSpecification developer2August 12, 2022000api.fda.gov
Dezhou Globalipl Medical Technology Co., Ltd.Dezhou Shandong, ChinaManufacturer2August 12, 2022000api.fda.gov
Medicreations LLCLas Vegas, NV, United StatesManufacturer, Repackager or relabeler2September 3, 2025000api.fda.gov
Shandong Huamei Technology Co.,ltd.Weifang Shandong, ChinaManufacturer2April 21, 2023000api.fda.gov
Smedtrum Medical Technology Co. Ltd.New Taipei City, TaiwanManufacturer2May 17, 2024000api.fda.gov
Aesthetic Protools, Inc.Scottsdale, AZ, United StatesRepackager or relabeler, Specification developer1December 1, 2023000api.fda.gov
Amt Engineering Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer1May 30, 2014000api.fda.gov
Beijing Adss Development Co., Ltd.Beijing, ChinaManufacturer1March 15, 2024000api.fda.gov
Beijing Honkon Technologies Co., Ltd.Beijing, ChinaManufacturer1October 18, 2013000api.fda.gov
Beijing Kes Biology Technology Co., Ltd.Beijing, ChinaManufacturer1January 22, 2013000api.fda.gov
Beijing Mingqiao Technology Co., Ltd.Beijing, ChinaExporter to the US, Manufacturer1November 27, 2019000api.fda.gov
Beijing Sincoheren Science & Technology Development Co., LtdBejing Beijing, ChinaManufacturer1February 11, 2013000api.fda.gov
Beijing Starlight Science & Technology Development Co., Ltd.Beijing, ChinaContract manufacturer, Manufacturer1March 8, 2011000api.fda.gov
Beijing Superlaser Technology Co., Ltd.Beijing, ChinaManufacturer1November 27, 2019000api.fda.gov
E-SwinHoudan Yvelines, FranceManufacturer1June 11, 2020000api.fda.gov
Formatk Systems Ltd.Tirat Hacarmel Northern, IsraelManufacturer1April 15, 2016000api.fda.gov
Guangzhou Enzoeys photoelectric Technology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer1August 21, 2024000api.fda.gov
Hebei Zhemai Technology Co.,ltdSanhe Hebei, ChinaManufacturer1December 1, 2023000api.fda.gov
Ids LtdPaju Gyeonggi, South KoreaManufacturer1October 5, 2018000api.fda.gov
Ids LtdGeumcheon-gu Seoul, South KoreaManufacturer1October 5, 2018000api.fda.gov
Inmode Ltd.Yokneam Northern, IsraelManufacturer1April 2, 2013000api.fda.gov
Jeisys Medical Inc.Seoul, South KoreaManufacturer1March 5, 2010000api.fda.gov
Kam Yuen Plastic Products Ltd.zhongshan Guangdong, ChinaManufacturer1December 2, 2021000api.fda.gov
Luvo Medical Technologies, Inc.Cambridge Ontario, CanadaManufacturer1March 5, 2020000api.fda.gov
Micowey Medical Equipment Guangxi Co., LtdWuzhou Guangxi, ChinaManufacturer1September 4, 2025000api.fda.gov
Nanjing Bestview Laser S&T Co.,ltd.Nanjing Jiangsu, ChinaManufacturer1November 14, 2024000api.fda.gov
Shanghai Apolo Medical Technology Co.,ltd.Shanghai, ChinaManufacturer1May 15, 2020000api.fda.gov
Shenzhen GSD Tech Co., LtdShenzhen Guangdong, ChinaManufacturer1November 16, 2009000api.fda.gov
Sanhe LEFIS Electronics Co.,Ltdlangfang Hebei, ChinaManufacturer1June 12, 2026000api.fda.gov
Solta Medical, Inc.Bothell, WA, United StatesManufacturer, Remanufacturer1June 5, 2012000api.fda.gov
Strata Skin Sciences, inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 4, 2013000api.fda.gov
Tentech Inc.Seoul, South KoreaComplaint file establishment, Exporter to the US, Manufacturer1November 10, 2022000api.fda.gov
Viora Ltd.Migdal HaEmek Northern, IsraelManufacturer1June 10, 2009000api.fda.gov
Atena (from The Imco Group) LtdNesher Haifa, IsraelContract manufacturer0000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
Beijing Beautemax Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Beijing Winkonlaser Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Biotec SRLDueville Vicenza, ItalyManufacturer0000api.fda.gov
Cyden LimitedSwansea, Wales, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
El Global Trade Ltd.Netanya Central, IsraelManufacturer, Specification developer0000api.fda.gov
Guangdong Fuqiang Beauty Equipment Co.,limitedQingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Telefield LimitedGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Lumenis Be LtdYokneam, Ha Zafon 2069236 Haifa, IsraelManufacturer, Specification developer0000api.fda.gov
M&T SRLrimini, ItalyManufacturer0000api.fda.gov
Miley Technology (hebei) Co., LtdHandan Hebei, ChinaManufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Nson Co., Ltd.Anyang Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
R.H. Electronics Ltd.Nof Hagalil Northern, IsraelContract manufacturer0000api.fda.gov
Sciton, Inc.Palo Alto, CA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Shanghai Bele Medical Technology Co.,ltdShanghai, ChinaManufacturer0000api.fda.gov
Sharplight Technologies Ltd.RISHON LEZION Tel Aviv, IsraelManufacturer0000api.fda.gov
Shenzhen Fansizhe Science And Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Silk'n Beauty Ltd.Rotterdam Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Shen Zhen HanShine Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Touchbeauty Beauty & Health (shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
VTech Communications LtdDONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Vydence Medical Industria e Comercio LtdaCEAT - Sao Carlos/SP Sao Paulo, BrazilManufacturer0000api.fda.gov
World Aesthetix LLCJacksonville, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xiamen Solex High-Tech Industries Co.,ltdXiamen Fujian, ChinaContract manufacturer0000api.fda.gov

Updated June 12, 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.