Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009736547

FEI Number

3009736547

Entity Name

Laser Marketing Group, LLC

City/State/Country

Lehi, UT, US

Establishment Address

103 N. 1100 W., Lehi, UT 84043, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Laser Marketing Group, LLC (Owner Number: 10041358)

Owner / Operator Contact Address

103 N. 1100 W., Lehi, UT 84043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191421

PMA Number

N/A

All Registered Proprietary Names

Palomar Vectus Syneron eMax VARILITE LASER VARILITE LASER SYSTEM TempSure System Venus Concepts Legacy, Legacy Pro Candela e-Los Plus Apollo Duet Spirit 918, spirit 918 Trio Alma Harmony XL Vbeam Perfecta Ultrapulse Encore Gentle Lase Pro Diamondtome Microderm RevLite Pro-Nox ALMA HARMONY Lumenis Lightsheer XC Candela Gentle Lase Pro Soprano Family platforms, Soprano XL, Soprano XLI, Soprano Ice and Soprano DUO Elite IQ Picosure Elite MPX Gentle Yag Pro-U Cryo 6 Cutera Excel V Elite + Fotona XP Dynamis Velashape M22and ResurFX Quanta Q-Plus C Xeo Clear & Brilliant Inmode Optimas Gyag Pro U Coolsculpt BBLs Inmode Optimas Picoway SOFWAVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-09-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-04-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-04-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-02-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-06
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-06-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-04-10
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-10-11
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2022-10-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-06-27
LNK	Laser For Gastro-Urology Use	General, Plastic Surgery	Class 2	878.4810	2020-07-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-03
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2020-07-03
HHR	Laser, Surgical, Gynecologic	Obstetrics/Gynecology	Class 2	884.4550	2020-07-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-04-04
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2020-04-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-09-29
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-03-10
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-03-10
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2023-03-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-04-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-03-31
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-12-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-12-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-02-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-12-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-03-31
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2023-03-31
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-02-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-09-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-08-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-08-21
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2023-08-21
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-08-31
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2022-02-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-02-02
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-02-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-04-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-10-11
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2022-02-15
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2023-04-04
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-04-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-04-13
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2022-02-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-06-14
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2022-06-14
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-06-14
ORK	Laser Assisted Lipolysis	General, Plastic Surgery	Class 2	878.4810	2022-06-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-03-31
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-09-22
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2021-10-22

Official Correspondent

Michael Goodrich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Laser Marketing Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009736547. Last updated year: 2026. Please use registration number 3009736547 when referencing this establishment in official correspondence.