Data / Medical devices / United States / Hyperion Medical

Hyperion Medical: FDA-registered device maker in Addison, TX, United States, 1 510(k) clearance

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

Hyperion Medical is registered with the FDA (registration 3007674911) in Addison, TX, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2015. 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: 3007674911
Address: 15932 Midway RD, Addison, TX, United States, 75001
Owner or operator: Hyperion Medical (10033629)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: November 6, 2015
Registered through: 2026
Brand names listed: Quanta Systems, STX4, Smart-RST

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Repackager or relabeler	accessdata.fda.gov
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	PDZ	2	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Test, Temperature Discrimination	LQW	1	Repackager or relabeler	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
October 27, 2015	K151629	Guardian 1000	GEX	Substantially Equivalent	Quanta System Spa	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
November 20, 2013	67814	Class II	Terminated	All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.	Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could	accessdata.fda.gov

Compare with other makers

Updated October 27, 2015. 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.