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510(k) Data Aggregation
K Number
K241601Device Name
EMS (FlexPulse, MagnaCore, Magnetika)
Manufacturer
CPMT LASER (Canadian Pioneer Medical Technology Corporation)
Date Cleared
2025-02-25
(266 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
CPMT LASER (Canadian Pioneer Medical Technology Corporation)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thigh
Device Description
The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.
The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.
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K Number
K232133Device Name
Co2 Laser System, Models: PureLase And VanLase
Manufacturer
CPMT Laser (Canadian Pioneer Medical Technology Corporation)
Date Cleared
2024-04-16
(273 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CPMT Laser (Canadian Pioneer Medical Technology Corporation)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Device Description
The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
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