Data / Medical devices / United States / Laser Marketing Group, LLC

Laser Marketing Group, LLC: FDA-registered device maker in Lehi, UT, United States, 58 510(k) clearances

Name: Laser Marketing Group, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Laser Marketing Group, LLC is registered with the FDA (registration 3009736547) in Lehi, UT, United States. It lists 19 device types. The FDA files 58 510(k) clearances under its listings, the newest dated August 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009736547
Address: 103 N. 1100 W., Lehi, UT, United States, 84043
Owner or operator: Laser Marketing Group, LLC (10041358)
Roles: Repackager or relabeler
First device listed: April 10, 2020
Registered through: 2026
Brand names listed: ALMA HARMONY, Alma Harmony XL, Alma Soprano XL, Apogee Elite, Apollo Duet, BBLs, BTL EMSELLA CHAIR, Candela Gentle Lase Pro and more

Devices it lists

Device	Product code	Class	Role	Source
Dermal Cooling Pack/Vacuum/Massager	OOK	2	Repackager or relabeler	accessdata.fda.gov
Dermatome	GFD	1	Repackager or relabeler	accessdata.fda.gov
Device, Iontophoresis, Other Uses	EGJ	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	OHV	2	Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Repackager or relabeler	accessdata.fda.gov
Laser Assisted Lipolysis	ORK	2	Repackager or relabeler	accessdata.fda.gov
Laser For Gastro-Urology Use	LNK	2	Repackager or relabeler	accessdata.fda.gov
Laser, Surgical, Gynecologic	HHR	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
Light, Ultraviolet, Dermatological	FTC	2	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Massager, Vacuum, Light Induced Heating	NUV	2	Repackager or relabeler	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Repackager or relabeler	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Repackager or relabeler	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	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
August 11, 2025	K251327	XERF	GEI	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
June 1, 2023	K230990	Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
March 1, 2023	K230308	Alma Harmony	GEX	Substantially Equivalent	Alma Lasers, Inc.	accessdata.fda.gov
October 13, 2022	K220853	PicoWay Laser System	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
August 25, 2022	K212253	Apollo Duet (Model : APD-4000)	PBX	Substantially Equivalent	Weero Co.	accessdata.fda.gov
March 30, 2021	K210226	PicoSure Workstation	GEX	Substantially Equivalent	Cynosure, LLC	accessdata.fda.gov
February 25, 2021	K202988	Tixel System	GEI	Substantially Equivalent	Novoxel , Ltd.	accessdata.fda.gov
May 26, 2020	K201111	GentleMax Pro Plus	GEX	Substantially Equivalent	Candela Corporation	accessdata.fda.gov
March 9, 2020	K193426	Elite iQ	GEX	Substantially Equivalent	Cynosure, LLC	accessdata.fda.gov
November 12, 2019	K192331	LaseMD LEO Laser System	GEX	Substantially Equivalent	Lutronic Global	accessdata.fda.gov
September 9, 2019	K191421	Sofacia System	OHV	Substantially Equivalent	Sofwave Medical, Ltd.	accessdata.fda.gov
September 6, 2019	K191528	Venus Legacy Pro Device	GEI	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
March 6, 2019	K182173	Joule System	GEX	Substantially Equivalent	Sciton, Inc	accessdata.fda.gov
November 14, 2018	K181497	HPM-6000UF	KPI	Substantially Equivalent	BTL Industries, Inc.	accessdata.fda.gov
October 24, 2018	K182365	TempSure System	GEI	Substantially Equivalent	Cynosure, Inc.	accessdata.fda.gov
June 1, 2018	K180189	InMode System with Fractora3D/3D-90 Applicators	GEI	Substantially Equivalent	Inmode MD , Ltd.	accessdata.fda.gov
January 9, 2018	K172193	Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules	GEX	Substantially Equivalent	Alma Lasers, Inc.	accessdata.fda.gov
December 8, 2017	K172302	InMode PLUS System	PBX	Substantially Equivalent	Inmode MD , Ltd.	accessdata.fda.gov
September 18, 2017	K170179	LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
August 9, 2017	K170060	M22 and ResurFx Systems	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
August 7, 2017	K170738	InMode Diolaze XL	GEX	Substantially Equivalent	Inmode MD , Ltd.	accessdata.fda.gov
March 9, 2016	K153671	Family of CoolGlide Aesthetic Lasers	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
February 12, 2016	K153718	Spirit Hair Removal laser Family	GEX	Substantially Equivalent	Active Optical Systems , Ltd.	accessdata.fda.gov
August 12, 2015	K151947	LightSheer Desire Light Laser System	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
June 30, 2015	K151331	The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
January 21, 2015	K142860	Lumenis M22 System	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
November 7, 2014	K140732	CANDELA GENTLELASE FAMILY OF LASER SYSTEMS	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
September 11, 2014	K141425	ELITE + LASER SYSTEM	GEX	Substantially Equivalent	Cynosure, Inc.	accessdata.fda.gov
May 9, 2014	K140122	CANDELA GENTLEMAX FAMILY OF LASER SYSTEM	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
December 6, 2013	K132185	FAMILY OF COOLGLIDE AESTHETIC LASERS	GEX	Substantially Equivalent	Cutera, Inc.	accessdata.fda.gov
September 6, 2013	K132431	THERMAGE CPT SYSTEM	GEI	Substantially Equivalent	Solta Medical, Inc.	accessdata.fda.gov
December 20, 2012	K123168	Q-PLUS T+ IPL LASER SYSTEM	GEX	Substantially Equivalent	Quanta System Spa	accessdata.fda.gov
September 17, 2012	K120235	MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP	GEX	Substantially Equivalent	Aerolase Medical Lasers, LLC	accessdata.fda.gov
September 13, 2012	K122579	VELASHAPE	NUV	Substantially Equivalent	Syneron Medical, Ltd.	accessdata.fda.gov
June 11, 2012	K113868	EPLUS SKIN TREATMENT SYSTEM	GEX	Substantially Equivalent	Syneron, Ltd.	accessdata.fda.gov
May 23, 2012	K120622	PALOMAR VECTUS LASER	GEX	Substantially Equivalent	Palomar Medical Technologies, Inc.	accessdata.fda.gov
May 2, 2012	K120023	ZELTIQ COOLSCULPTING	OOK	Substantially Equivalent	Zeltiq Aesthetics, Inc.	accessdata.fda.gov
April 30, 2012	K113687	EQUINOX RELIEVE	BZR	Substantially Equivalent	O-Two Medical Technologies, Inc.	accessdata.fda.gov
April 2, 2012	K120433	CLEAR + BRILLIANT LASER SYSTEM	ONG	Substantially Equivalent	Solta Medical, Inc.	accessdata.fda.gov
March 28, 2012	K113702	FOTONA XP ND: YAG LASER SYSTEM	PDZ	Substantially Equivalent	Fotona D.D.	accessdata.fda.gov
June 22, 2011	K110907	PALOMAR ICON (TM) AESTHETIC SYSTEM	GEX	Substantially Equivalent	Palomar Medical Technologies, Inc.	accessdata.fda.gov
March 18, 2011	K101916	JOULE MULTI-PLATFORM SYSTEM	GEX	Substantially Equivalent	Sciton, Inc	accessdata.fda.gov
May 13, 2009	K091169	ELITE MPX LASER SYSTEM WITH CRYO C	GEX	Substantially Equivalent	Cynosure, Inc.	accessdata.fda.gov
April 14, 2009	K090618	CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C	GEX	Substantially Equivalent	Cynosure, Inc.	accessdata.fda.gov
April 14, 2009	K083848	ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM	GEX	Substantially Equivalent	Alma Lasers , Ltd.	accessdata.fda.gov
May 23, 2008	K072564	ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM	GEX	Substantially Equivalent	Alma Lasers , Ltd.	accessdata.fda.gov
May 2, 2007	K070388	PROFILE MULTI-PLATFORM SYSTEM	GEX	Substantially Equivalent	Sciton, Inc	accessdata.fda.gov
December 1, 2006	K063112	REVLITE Q-SWITCHED ND:YAG LASER	GEX	Substantially Equivalent	Hoya Conbio, Inc.	accessdata.fda.gov
February 24, 2006	K060395	CRYO, MODEL V6.0	GEX	Substantially Equivalent	Zimmer Elektromedizin GmbH	accessdata.fda.gov
February 9, 2005	K043251	CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
November 8, 2004	K041959	POLARIS DS/COMET	GEX	Substantially Equivalent	Syneron Medical, Ltd.	accessdata.fda.gov
September 10, 2004	K041930	VARILITE LASER SYSTEM	GEX	Substantially Equivalent	Iridex Corporation	accessdata.fda.gov
March 10, 2004	K033549	STARLUX PULSED LIGHT SYSTEM	GEX	Substantially Equivalent	Palomar Medical Products, Inc.	accessdata.fda.gov
October 30, 2003	K033172	CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
June 4, 2003	K031488	CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER	GEX	Substantially Equivalent	Cynosure, Inc.	accessdata.fda.gov
April 15, 2003	K030147	LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
March 31, 2003	K024371	CANDELA GENTLE LASE FAMILY OF LASER SYSTEM	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov
December 20, 2002	K023193	CANDELA GENTLE YAG LASER SYSTEM	GEX	Substantially Equivalent	Candela Corp.	accessdata.fda.gov

Compare with other makers

Updated August 11, 2025. 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.