FDA & Compliance
At FoliviaX™, product safety, quality assurance, and regulatory compliance are fundamental to everything we do.
We are committed to providing customers with transparent information regarding the technology platforms, manufacturing standards, and regulatory clearances associated with selected FoliviaX™ devices.
FDA 510(k) Clearance Information
Certain FoliviaX™ products are manufactured on medical-device platforms that have received United States FDA 510(k) clearance through the original manufacturer.
These clearances confirm that the devices were reviewed under applicable FDA procedures and were determined to be substantially equivalent to legally marketed predicate devices.
📋 FDA Clearance Number: K222477
Applicable Products:
- FoliviaX Pro™ (LS-D630)
- FoliviaX Elite™ (LS-D620)
Status: ✅ FDA 510(k) Cleared
Manufacturer: Dongguan Lescolton Medical Device Co., Ltd.
📋 FDA Clearance Number: K210169
Applicable Product:
- FoliviaX Essential™ (LS-D601)
Status: ✅ FDA 510(k) Cleared
Manufacturer: Dongguan Lescolton Medical Device Co., Ltd.
🏭 Manufacturing & Quality Standards
FoliviaX™ works with experienced manufacturing partners that operate under established quality-management systems and regulatory requirements.
Our manufacturing partners maintain the technical documentation, testing records, and compliance procedures required for product manufacturing and regulatory support.
All products are manufactured according to strict quality-control procedures designed to ensure consistency, reliability, and customer satisfaction.
🔍 Transparency Commitment
We believe customers deserve clear and honest information regarding the products they purchase.
For regulatory inquiries or additional documentation requests, please contact:
support@foliviax.com
⚠️ Important Notice
FoliviaX™ is an independent consumer brand.
FDA clearances referenced on this page are held by the original manufacturer of the applicable medical-device platforms.
References to FDA clearance are provided solely to accurately describe the regulatory status of the underlying device platforms used in applicable products.
Individual results may vary.
No product sold on this website is intended to diagnose, treat, cure, or prevent any disease unless specifically indicated under applicable regulatory requirements.