Write your store's popup content
FDA Certified & Safety Verified
Your Eyes Deserve
Certified Safety
Every Savvenart lens is manufactured by an FDA 510(k)-cleared, ISO 13485:2016-certified facility — so you can wear with complete confidence.
510(k) Premarket Notification Cleared
No. K220143
13485 :2016 Certified Quality System
Reg. No. SX 2403434-1
Before Shipment
Our Certifications, Explained
These are not marketing claims — they are independently verified credentials issued by recognized regulatory bodies.
FDA 510(k) Premarket Notification
Our lenses have received FDA 510(k) clearance — a rigorous premarket review confirming they are substantially equivalent to a legally marketed predicate device. This is the FDA's standard pathway for medical devices including soft contact lenses.
Device: Soft Contact Lens, Daily Wear (Hydrophilic)
Decision: Substantially Equivalent (SE)
Decision Date: September 8, 2022
Applicant: Shenzhen Dashicheng Optical Technology Co., Ltd.
ISO 13485:2016 Quality Management System
Our manufacturing partner holds ISO 13485:2016 certification — the global gold standard for medical device quality management. This standard governs every stage of production, from raw material sourcing to final inspection and distribution.
Registration No.: SX 2403434-1
Scope: Design, Development, Manufacture & Distribution of Soft Contact Lenses
Certificate Holder: Shenzhen Dashicheng Optical Technology Co., Ltd.
Controlled Manufacturing Facility
Lenses are produced at a dedicated optical manufacturing facility in Shenzhen, China, operating under strict cleanroom conditions and full traceability protocols required by both FDA and ISO 13485 standards.
Location: Wanjieining Industrial Park, No. 1450, Guanguang Road, Longhua District, Shenzhen, 518100, China
What This Means for You
Real certifications translate into real, tangible protections for every customer.
FDA-Cleared Device510(k) clearance means the FDA has reviewed our lens design and confirmed it meets safety and effectiveness standards for daily wear soft contact lenses.
Third-Party Audited QualityISO 13485 certification requires independent audits, ensuring our quality system is continuously maintained and verified — not self-declared.
Sterile PackagingLenses are sealed in sterile, single-use blister packs that maintain safety from factory to your eyes.
Colorant SafetyAll pigments are encapsulated within the lens material using a sandwich construction — never in direct contact with your cornea.
Traceable MaterialsEvery material is documented and traceable under ISO 13485 supplier management requirements — no unknown components.
Batch Quality ControlEvery production batch undergoes inspection before release, with full records maintained under certified quality protocols.
From Factory to Your Eyes
A transparent look at how our lenses are made and verified.
Raw Material Qualification
Only approved, biocompatible materials are accepted into production. Suppliers are evaluated and qualified under ISO 13485 supplier management requirements.
Precision Lens Casting
Lenses are cast in controlled cleanroom environments. Dimensional parameters — diameter, base curve, center thickness — are monitored throughout production.
Color Application & Encapsulation
Cosmetic pigments are applied using a sandwich encapsulation method, locking color between lens layers so it never contacts the ocular surface.
Sterilization & Packaging
Finished lenses are sterilized and sealed in individual blister packs with buffered saline solution. Sterility is validated and maintained through the product's shelf life.
Final Inspection & Release
Each batch undergoes final quality review before release. Only lots that pass all acceptance criteria are approved for sale and shipment.
Common Questions About Safety & Certifications
Honest answers to what customers ask most.
What is FDA 510(k) clearance?
510(k) is the FDA's premarket notification process for medical devices. A manufacturer must demonstrate that their device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. Our lenses received 510(k) clearance (K220143) on September 8, 2022.
What is ISO 13485:2016?
ISO 13485:2016 is the international standard for quality management systems specific to medical device manufacturing. It requires documented processes, supplier controls, traceability, and regular independent audits — ensuring consistent product quality across every batch.
Are Savvenart lenses safe for daily wear?
Yes — when used as directed. Our daily lenses are designed for single-day use and should be discarded after each wear. Always wash hands before handling lenses and follow the care instructions included with your order.
Do I need a prescription to buy colored contacts?
In the United States, contact lenses — including cosmetic lenses with no vision correction — are regulated as medical devices and legally require a valid prescription. We encourage all customers to consult a licensed eye care professional before purchasing.
Are the colors in the lenses safe for my eyes?
Yes. All colorants used in Savvenart lenses are encapsulated within the lens material using a sandwich construction method. The pigment layer is sealed between two layers of lens polymer and does not come into contact with your cornea or ocular surface.
Our Commitment to You
We will never compromise on the safety of our products. Every lens that leaves our facility has been manufactured, inspected, and packaged under FDA 510(k)-cleared and ISO 13485:2016-certified standards — because your trust is the foundation of everything we do.
Shop Certified Lenses
Savvenart-where eyes tell the
deepest stories.
Premium colored contact lenses
for every look.
Savvenart-where eyes tell the
deepest stories.
Premium colored contact lenses
for every look.