We are thrilled to announce that our cutting-edge electromagnetic muscle building beauty device has received the prestigious FDA 510(k) Premarket Notification, marking a significant milestone for Jontelaser. This certification reaffirms our commitment to delivering innovative and high-quality beauty and medical devices to our valued customers.
About the FDA Certification
The FDA 510(k) clearance, specifically for the “Body Contouring Machine” (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13), is a testament to the safety and efficacy of our muscle stimulator designed for muscle conditioning. This device has been thoroughly evaluated and found to be substantially equivalent (SESE) to existing legally marketed devices, ensuring that it meets stringent regulatory standards.
Key Details from the FDA Notification:
510(k) Number: K232181
Device Name: Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
Regulation Number: 890.5850
Classification Product Code: NGX
Date Received: 07/24/2023
Decision Date: 04/24/2024
Regulation Medical Specialty: Physical Medicine
Our Commitment to Quality and Innovation
With over 20 years of experience, Jontelaser has been at the forefront of manufacturing and supplying top-notch beauty and medical systems. Our modern factories, equipped with 300,000-level clean production workshops, ensure that every device we produce meets the highest standards of quality and safety.
Our international presence, with trademarks registered in 240 countries and exports to the Americas, Europe, Southeast Asia, the Middle East, and Africa, underscores our dedication to bringing advanced beauty solutions to a global audience.
About the Electromagnetic Muscle Building Beauty Device
Our electromagnetic muscle building beauty device features:
2 Handles: Designed for ease of use and versatility.
Italian Design: A sleek and sophisticated appearance crafted by an Italian designer.
15 Tesla Strength: Ensuring powerful and effective muscle stimulation.
RF Function: Integrated radiofrequency function on the handles for enhanced treatment outcomes.
Join Us in Celebrating This Achievement
We invite our customers and partners to join us in celebrating this significant achievement. The FDA certification of our electromagnetic muscle building beauty device is a step forward in our mission to provide innovative and reliable beauty solutions.
For more information about our products and this exciting development, please visit our website or contact us directly.
Contact Information:
Website: www.jontelaser.com
Email: [email protected]
Phone: 86-18617782197
Thank you for your continued support and trust in Jontelaser.