Skip to the page
Get started free

Data / Medical devices / Powered Laser Surgical Instrument / United States

FDA-registered makers of Powered Laser Surgical Instrument in the United States: 129 establishments

129 establishments in the United States are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX). 95 have a 510(k) clearance or PMA approval on file and 22 have a recall event. 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 of this device in the United StatesWatch these makers
Device
Powered Laser Surgical Instrument
Product code
GEX
Country
United States

Makers of Powered Laser Surgical Instrument in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer58June 17, 2026010api.fda.gov
Trimedyne, Inc.Corona, CA, United StatesManufacturer, Specification developer21December 21, 2005000api.fda.gov
Omni-Guide Holdings, Inc.Billerica, MA, United StatesComplaint file establishment, Manufacturer, Specification developer19April 21, 2023010api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export17May 18, 2026000api.fda.gov
Iridex CorporationSan Jose, CA, United StatesManufacturer17September 5, 2018000api.fda.gov
Iridex CorporationMountain View, CA, United StatesManufacturer17September 5, 2018010api.fda.gov
Monteris Medical CorpMinnetonka, MN, United StatesComplaint file establishment, Manufacturer16December 8, 2023032api.fda.gov
Biolase MG LLCCorona, CA, United StatesComplaint file establishment, Manufacturer11April 21, 2022000api.fda.gov
Biolase MG LLCFoothill Ranch, CA, United StatesSpecification developer11April 21, 2022010api.fda.gov
Candela CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer11June 1, 2023000api.fda.gov
Wisdom Medical TechnologiesDalton Gardens, ID, United StatesManufacturer, Repackager or relabeler11September 1, 2021000api.fda.gov
Dornier Medtech America, Inc.Kennesaw, GA, United StatesComplaint file establishment, Manufacturer10November 24, 2025010api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer9July 20, 2023030api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer9July 20, 2023000api.fda.gov
Rohrer Aesthetics, Inc.Homewood, AL, United StatesComplaint file establishment, Specification developer9September 26, 2025000api.fda.gov
Solta Medical, Inc.Bothell, WA, United StatesManufacturer, Remanufacturer, Repackager or relabeler, Specification developer9August 21, 2024000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer8July 9, 2025060api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Specification developer8July 30, 2018020api.fda.gov
Laser Peripherals LLC.Plymouth, MN, United StatesContract manufacturer, Manufacturer8June 8, 2017010api.fda.gov
Cao Group, Inc.W Jordan, UT, United StatesComplaint file establishment, Contract manufacturer, Manufacturer7March 11, 2026010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer7July 30, 2018000api.fda.gov
Lightscalpel IncBothell, WA, United StatesContract manufacturer, Manufacturer, Specification developer7February 15, 2023000api.fda.gov
CPMT Laser Usa LLCMiami, FL, United StatesManufacturer6April 16, 2024000api.fda.gov
Cutera, Inc.Brisbane, CA, United StatesManufacturer6July 11, 2025000api.fda.gov
Focus Medical, LLC.Bethel, CT, United StatesManufacturer, Specification developer6September 1, 2015000api.fda.gov
Medicreations LLCLas Vegas, NV, United StatesManufacturer, Repackager or relabeler6December 20, 2024000api.fda.gov
AMO Manufacturing USA, LLCMilpitas, CA, United StatesManufacturer, Specification developer5January 6, 2015000api.fda.gov
Lasetech, LLCLawrenceville, NJ, United StatesManufacturer5April 3, 2012000api.fda.gov
Strata Skin Sciences, inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer5January 14, 2020010api.fda.gov
Transamerican Technologies InternationalSan Ramon, CA, United StatesManufacturer, Repackager or relabeler5November 13, 1996000api.fda.gov
Innovaquartz LLCPhoenix, AZ, United StatesManufacturer4May 3, 2024000api.fda.gov
Sciton, Inc.Palo Alto, CA, United StatesComplaint file establishment, Manufacturer, Remanufacturer4July 19, 2022000api.fda.gov
The Lotus Global Group, Inc.Napa, CA, United StatesSpecification developer4August 9, 2005000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Specification developer4January 7, 2010020api.fda.gov
World Aesthetix LLCJacksonville, FL, United StatesComplaint file establishment, Specification developer4May 20, 2024000api.fda.gov
Xintec CorporationAlameda, CA, United StatesManufacturer4November 9, 2021020api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3July 9, 2025000api.fda.gov
Convergent DentalWaltham, MA, United StatesManufacturer3September 23, 2015010api.fda.gov
DDC Technologies, Inc.Oceanside, NY, United StatesManufacturer3April 7, 2004000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer3July 25, 2014000api.fda.gov
Ipg Medical CorporationMarlborough, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3September 19, 2025010api.fda.gov
Lumenis Be Inc.Salt Lake City, UT, United StatesManufacturer3February 28, 2017020api.fda.gov
Millennium Dental Technologies, Inc.Cerritos, CA, United StatesManufacturer3July 12, 2019000api.fda.gov
WEINERT Fiber Optics Inc.Williamsburg, VA, United StatesManufacturer3July 30, 2021000api.fda.gov
Aerolase CorporationTarrytown, NY, United StatesManufacturer2September 17, 2012020api.fda.gov
Aesthetic Protools, Inc.Scottsdale, AZ, United StatesRepackager or relabeler, Specification developer2September 3, 2025000api.fda.gov
Azena MedicalWalnut Creek, CA, United StatesManufacturer, Specification developer2February 20, 2020000api.fda.gov
Acclaro CorporationSmithfield, RI, United StatesManufacturer2May 8, 2024000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Manufacturer, Specification developer2March 17, 2026000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer, Repackager or relabeler2May 11, 2004010api.fda.gov
InnoVoyce LLCBoston, MA, United StatesComplaint file establishment, Specification developer2May 29, 2024000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer2April 25, 2008000api.fda.gov
Launch DevelopmentDalton Gardens, ID, United StatesRepackager or relabeler, Specification developer2May 1, 2024000api.fda.gov
LiteCure, LLCFort Worth, TX, United StatesManufacturer2February 22, 2018000api.fda.gov
Neauvia North America, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer2July 17, 2023000api.fda.gov
Novian Health Inc.Chicago, IL, United StatesSpecification developer2February 26, 2016000api.fda.gov
Raja Trading Company, Inc.Fairfax, VA, United StatesManufacturer, Repackager or relabeler2December 2, 2021000api.fda.gov
Venus Concept Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 9, 2020000api.fda.gov
Venus Concept Inc.Windham, NH, United StatesComplaint file establishment, Manufacturer, Specification developer2June 9, 2020000api.fda.gov
W And R Investments, LLCMilford, MA, United StatesManufacturer2July 30, 2021000api.fda.gov
Accure Acne, Inc.Boulder, CO, United StatesSpecification developer1October 11, 2024010api.fda.gov
Beaver-Visitec International, IncLittle Silver, NJ, United StatesManufacturer1November 22, 2004000api.fda.gov
Beyond International Inc.Sugar Land, TX, United StatesManufacturer1July 18, 2013000api.fda.gov
Coloplast Manufacturing Us, LLCMinneapolis, MN, United StatesSpecification developer1December 10, 2018000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1February 28, 1995000api.fda.gov
CovidienNorth Haven, CT, United StatesRepackager or relabeler, Specification developer1January 5, 1995000api.fda.gov
CovidienPonce, PR, United StatesManufacturer1January 5, 1995000api.fda.gov
Dawell Medical, LLCCutler Bay, FL, United StatesComplaint file establishment, Specification developer1October 14, 2025000api.fda.gov
DermaqualJohnson City, TN, United StatesRepackager or relabeler, Specification developer1December 23, 2015000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesComplaint file establishment, Specification developer1February 22, 2018000api.fda.gov
Elixir MD IncIrvine, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1July 8, 2024000api.fda.gov
Enamel Pure Inc.Worcester, MA, United StatesComplaint file establishment, Specification developer1March 25, 2024000api.fda.gov
Fabinject LLCWinter Park, FL, United StatesManufacturer, Repackager or relabeler1October 18, 2024000api.fda.gov
Fiberoptic FabricationsWilbraham, MA, United StatesManufacturer, Specification developer1June 28, 2012000api.fda.gov
General Aesthetic ManufacturingPark City, UT, United StatesSpecification developer1February 2, 2022000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1August 23, 2024000api.fda.gov
HydraFacial LLCLong Beach, CA, United StatesManufacturer1July 20, 2006000api.fda.gov
I.C. Medical, Inc.Phoenix, AZ, United StatesManufacturer1July 28, 1993000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer, Repackager or relabeler1December 14, 2007000api.fda.gov
Laser Engineering, Inc.Nashville, TN, United StatesManufacturer1September 22, 2022000api.fda.gov
LightwavePhoenix, AZ, United StatesManufacturer1January 4, 2010000api.fda.gov
Laser Dental InnovationsSan Jose, CA, United StatesManufacturer1January 18, 2000000api.fda.gov
Med-Fibers, Inc.Chandler, AZ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1January 17, 2013000api.fda.gov
Medical Energy, Inc.Pensacola, FL, United StatesManufacturer1August 26, 2004000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer, Specification developer1March 1, 2006050api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesComplaint file establishment, Manufacturer1March 1, 2006000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1January 5, 1995000api.fda.gov
Norco, Inc.Boise, ID, United StatesManufacturer1October 19, 1990000api.fda.gov
Ophthalmed LLCRoswell, GA, United StatesManufacturer1August 20, 2002000api.fda.gov
Optical Integrity, Inc.P C Beach, FL, United StatesManufacturer, Specification developer1October 16, 2002000api.fda.gov
Preferred DepotIrvine, CA, United StatesRemanufacturer, Repackager or relabeler1October 7, 2022000api.fda.gov
Peregrine Surgical, LLC.New Britain, PA, United StatesContract manufacturer, Manufacturer1March 7, 2003000api.fda.gov
Photonica USA LLCCocoa Beach, FL, United StatesComplaint file establishment, Manufacturer1February 24, 2015000api.fda.gov
Sparqtron Corp.Fremont, CA, United StatesContract manufacturer, Manufacturer1November 8, 2006000api.fda.gov
Tria Laser IncLivermore, CA, United StatesSpecification developer1December 23, 2009000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
All Quality & Services, Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
All Quality & Services, Inc.Garland, TX, United StatesContract manufacturer0000api.fda.gov
Angstrom MFG., Inc.Sainte Genevieve, MO, United StatesContract manufacturer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Sunrise, FL, United StatesContract manufacturer0000api.fda.gov
Coronado Aesthetics LLCSouthlake, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cure Point Therapeutics, IncSanta Monica, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dentlight Inc.Plano, TX, United StatesManufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer0000api.fda.gov
Erchonia CorporationFountain Inn, SC, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Gener8San Jose, CA, United StatesContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Ipg Medical CorporationSalem, NH, United StatesContract manufacturer0000api.fda.gov
InnofiberSterling, MA, United StatesContract manufacturer0000api.fda.gov
Lightera, LLCAvon, CT, United StatesContract manufacturer0000api.fda.gov
Medical Quant UsaSolon, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer0020api.fda.gov
Norlase INCRedwood City, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Oxid CorporationNovi, MI, United StatesContract manufacturer0000api.fda.gov
Oncore Manufacturing, LLC dba NEOTechFremont, CA, United StatesContract manufacturer0000api.fda.gov
Pioneer Optics Co.East Granby, CT, United StatesContract manufacturer0000api.fda.gov
Polymicro Technologies, A Subsidiary Of MolexPhoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Precision Impacts LLCMiamisburg, OH, United StatesContract manufacturer0000api.fda.gov
Product Resources, LLC.Newburyport, MA, United StatesContract manufacturer0000api.fda.gov
Psoria-Shield IncUtica, NY, United StatesManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
RH Usa, Inc.Livermore, CA, United StatesContract manufacturer0000api.fda.gov
SpecialteamChino, CA, United StatesContract manufacturer0000api.fda.gov
Sterigenics US LLCLos Angeles, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.