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Spectrum Brands, Inc. (a Delaware Corporation): FDA-registered device maker in Middleton, WI, United States, 5 510(k) clearances

Name: Spectrum Brands, Inc. (a Delaware Corporation) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spectrum Brands, Inc. (a Delaware Corporation) is registered with the FDA (registration 3005855240) in Middleton, WI, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 22, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005855240
Address: 3001 Deming Way, Middleton, WI, United States, 53562
Owner or operator: Spectrum Brands, Inc. (a Delaware Corporation) (10034410)
Roles: Complaint file establishment, Specification developer
First device listed: November 30, 2010
Registered through: 2026
Brand names listed: LumaRx MINI IPL Skin Beauty System model IPL2000, LumaRx MINI IPL Skin Beauty System model IPL6800, LumaRx Pro, iLIGHT Elite Face and Body, iLIGHT Pro PLUS, iLIGHT Pro PLUS Quartz, iLIGHT Pro, Ilight Pro Premier, iLIGHT Ultra Face and Body

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Complaint file establishment	accessdata.fda.gov
Razor, Surgical	LWK	1	Specification developer	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
July 22, 2014	K141583	SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY	ONF	Substantially Equivalent	Shaser, Inc.	accessdata.fda.gov
May 16, 2014	K140631	LUMENA FH HAIR REMOVAL SYSTEM	ONF	Substantially Equivalent	Shaser, Inc.	accessdata.fda.gov
February 12, 2014	K133201	SHASER V-MINI 2 HAIR REMOVAL SYSTEM	ONF	Substantially Equivalent	Shaser, Inc.	accessdata.fda.gov
May 25, 2012	K120080	SHASER HRS2 HAIR REMOVAL SYSTEM	ONF	Substantially Equivalent	Shaser, Inc.	accessdata.fda.gov
May 18, 2011	K103560	SHASER IPL HAIR REMOVAL SYSTEM	ONF	Substantially Equivalent	Shaser, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 22, 2014. 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.