MEDICAL QUANT USA

FDA Device Registration & Listing · Solon, OH, US · Registration 3005730446

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005730446
FEI Number
3005730446
Entity Name
MEDICAL QUANT USA
City/State/Country
Solon, OH, US
Establishment Address
6521 Davis Industrial Pkwy, Solon, OH 44139, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Multi Radiance Medical (Owner Number: 9087202)
Owner / Operator Contact Address
6521 Davis Industrial Parkway, Solon, OH 44139, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K080102
PMA Number
N/A

All Registered Proprietary Names

Laser STIM Target Emitter Contoura Laser Stim Laser Stim MR5 Activ Pro TQ Laser TQ Solo Laser TerraQuant Laser TQ Solo Portable Laser TerraQuant Pro MR5 ACTIV PRO MR5 ACTIV PRO LASER STIM MR5 ACTIV Pro LaserShower MR4 ACTIV HOLISTIC BODY SHOP RELIEF+ Fibrolux LS50 Emitter MR4 Se 25 Laser MR4 Super Pulsed Laser MR4 LaserStim Emitter MR4 Activ MR4 SE25 Standard Emitter MR4 Ultra PainAway Laser Shower LS50 MR4 LaserShower 50 4-D Emitter MR4 Laser TQ Solo

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 2012-06-01
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2012-06-01
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2012-06-01
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2026-06-02
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2012-06-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-06-01
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2017-07-24
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2022-11-03
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2012-06-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-06-01

Official Correspondent

Glenn Persello

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Multi Radiance Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005739661 MILTA PKP-GIT Moscow Moskva, RU

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, PA***SLT Fiber Delivery System***Sterile***Non-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005730446. Last updated year: 2026. Please use registration number 3005730446 when referencing this establishment in official correspondence.
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