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Data / Medical devices / Powered Laser Surgical Instrument With MicrobeamFractional Output

Powered Laser Surgical Instrument With MicrobeamFractional Output (ONG): 44 FDA-registered makers in 8 countries

44 establishments in 8 countries are registered with the FDA to make Powered Laser Surgical Instrument With MicrobeamFractional Output (product code ONG, Class 2, 21 CFR 878.4810). 19 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on October 20, 2025, and lists 4 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 the United StatesWatch this device
Product code
ONG
Device class
2
Regulation
878.4810
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States13
South Korea10
China9
Israel5
Italy3
France2
Thailand1
Slovenia1

Makers of Powered Laser Surgical Instrument With MicrobeamFractional Output

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
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler4January 2, 2024000api.fda.gov
Solta Medical, Inc.Bothell, WA, United StatesManufacturer, Remanufacturer, Specification developer4April 2, 2012000api.fda.gov
Cynosure Lutronic Technology CorporationGoyang Gyeonggi, South KoreaManufacturer2July 31, 2025000api.fda.gov
Shanghai Apolo Medical Technology Co.,ltd.Shanghai, ChinaManufacturer2July 2, 2025000api.fda.gov
Alma Lasers Ltd.CAESAREA Northern, IsraelManufacturer1October 29, 2009000api.fda.gov
Avava, Inc.Waltham, MA, United StatesComplaint file establishment, Manufacturer, Specification developer1November 21, 2022000api.fda.gov
Beijing Perfectlaser Technology Co.,ltdBeijing, ChinaExporter to the US, Manufacturer1July 6, 2017000api.fda.gov
Beijing Sincoheren Science & Technology Development Co., LtdBejing Beijing, ChinaManufacturer1July 6, 2017000api.fda.gov
Focus Medical, LLC.Bethel, CT, United StatesManufacturer1April 12, 2012000api.fda.gov
Ids LtdPaju Gyeonggi, South KoreaManufacturer1February 2, 2018010api.fda.gov
Jeisys Medical Inc.Seoul, South KoreaManufacturer1November 10, 2010000api.fda.gov
Lasering S.R.L.MODENA Emilia-Romagna, ItalyManufacturer1July 22, 2011000api.fda.gov
Lutronic CorporationGoyang-si Gyeonggi, South KoreaManufacturer1January 20, 2011000api.fda.gov
Olemy Laser Technology LtdWuxi Jiangsu, ChinaManufacturer1November 30, 2018000api.fda.gov
Paradigm Medical Technologies CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer1June 3, 2022000api.fda.gov
Sanhe Jumei Technology Co.,ltdSanhe Hebei, ChinaExporter to the US, Manufacturer1July 6, 2017000api.fda.gov
SRMC Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer1December 24, 2014000api.fda.gov
Tria Laser IncLivermore, CA, United StatesSpecification developer1October 25, 2013000api.fda.gov
Wingderm Electro-Optics Ltd.Beijing, ChinaExporter to the US, Manufacturer1April 30, 2020010api.fda.gov
Amt Engineering Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Atena (from The Imco Group) LtdNesher Haifa, IsraelContract manufacturer0000api.fda.gov
Acclaro CorporationSmithfield, RI, United StatesManufacturer0000api.fda.gov
Beijing Beautemax Technology LimitedBeijing, ChinaContract manufacturer0000api.fda.gov
Beijing Winkonlaser Technology LimitedBeijing, ChinaExporter to the US, Manufacturer0000api.fda.gov
Benchmark Electronics (thailand) Public Company LiAYUDHAYA Phra Nakhon Si Ayutthaya, ThailandContract manufacturer0000api.fda.gov
Biolase MG LLCCorona, CA, United StatesManufacturer0000api.fda.gov
Biolase MG LLCFoothill Ranch, CA, United StatesSpecification developer0000api.fda.gov
Bison Medical Co., LtdGeumcheon gu Seoul, South KoreaManufacturer0000api.fda.gov
BLUECORE COMPANY Co., Ltd.Yangsan Gyeongnam, South KoreaManufacturer0000api.fda.gov
Classys IncAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
E-SwinHoudan Yvelines, FranceManufacturer0000api.fda.gov
El.en. Electronic Engineering SPACALENZANO Firenze, ItalyManufacturer0000api.fda.gov
Fotona D.O.O.Ljubljana, SloveniaManufacturer0000api.fda.gov
Lumenis Be LtdYokneam, Ha Zafon 2069236 Haifa, IsraelManufacturer, Specification developer0000api.fda.gov
M&T SRLrimini, ItalyManufacturer0000api.fda.gov
Quantel MedicalCOURNON AUVERGNE Puy-de-Dome, FranceContract manufacturer0000api.fda.gov
R.H. Electronics Ltd.Nof Hagalil Northern, IsraelContract manufacturer0000api.fda.gov
RH Usa, Inc.Livermore, CA, United StatesContract manufacturer0000api.fda.gov
Sciton, Inc.Palo Alto, CA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Sharplight Technologies Ltd.RISHON LEZION Tel Aviv, IsraelManufacturer0000api.fda.gov
SNJ Co LtdGuro-Gu Seoul, South KoreaManufacturer0000api.fda.gov
SanminaSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Weifang Mingliang Electronics Co.,ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov

Updated October 20, 2025. 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.