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Wisdom Medical Technologies: FDA-registered device maker in Dalton Gardens, ID, United States, 11 510(k) clearances

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

Wisdom Medical Technologies is registered with the FDA (registration 3013532143) in Dalton Gardens, ID, United States. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013532143
Address: 7791 Aqua Circle, Suite 7G, Dalton Gardens, ID, United States, 83815
Owner or operator: Wisdom Medical Technologies (10054590)
Roles: Manufacturer, Repackager or relabeler
First device listed: April 5, 2017
Registered through: 2026
Brand names listed: Ceramoptec AP-400-15, ELVeS® Radial®, ELVeS® Radial® Kit, MegaBeam® Endo-ENT Probe, MegaBeam® Reusable, MegaBeam® Single Use, Twister Side-Fiber Optic Delivery System

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer, 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
September 1, 2021	K210951	Leonardo Mini Blue	GEX	Substantially Equivalent	Ceramoptec GmbH	accessdata.fda.gov
April 17, 2014	K133006	NEOV DIODE LASER FAMILY	GEX	Substantially Equivalent	G.N.S Neolaser , Ltd.	accessdata.fda.gov
April 24, 2012	K120231	EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
March 13, 2012	K113688	MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
January 24, 2012	K113858	MEGABEAM ENDO-ENT PROBE	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
January 20, 2012	K113709	MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
December 16, 2011	K112987	TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
November 3, 2011	K112299	ENDOVASCULAR LASER VEIN SYSTEM KIT	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
September 30, 2011	K112442	RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM	GEX	Substantially Equivalent	Biolitec Medical Devices, Inc.	accessdata.fda.gov
September 20, 2011	K112253	CERALAS 147NM DIODE LASER SYSTEM	GEX	Substantially Equivalent	Biolitec, Inc.	accessdata.fda.gov
September 15, 2010	K100726	CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM	GEX	Substantially Equivalent	Biolitec, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 1, 2021. 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.