Data / Medical devices / United States / Ipg Medical Corporation

Ipg Medical Corporation: FDA-registered device maker in Marlborough, MA, United States, 3 510(k) clearances

Name: Ipg Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ipg Medical Corporation is registered with the FDA (registration 3020221089) in Marlborough, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 19, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3020221089
Address: 225 Cedar Hill Street, Marlborough, MA, United States, 01752
Owner or operator: IPG Medical Corporation (10061387)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: October 17, 2024
Registered through: 2026
Brand names listed: Powered laser surgical instrument

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Contract manufacturer, 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
September 19, 2025	K251100	IPGTFL-02	GEX	Substantially Equivalent	Ipg Medical Corporation	accessdata.fda.gov
May 28, 2024	K233344	Regenalase Laser System	GEX	Substantially Equivalent	Ipg Medical	accessdata.fda.gov
March 21, 2024	K232568	IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories	GEX	Substantially Equivalent	Ipg Medical Corporation	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 5, 2026	99064	Class II	Ongoing	Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.	Software anomaly that causes a false display of error code 5018.	accessdata.fda.gov

Compare with other makers

Updated June 24, 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.