The Regulatory Standard
FDA 510(k) Clearance
The Verso Visage is not just a skincare device. It is a federally cleared medical technology, proven safe and effective for treating acne and wrinkles.
FDA 510(k) Cleared
K233114
Verso Visage LED Mask
Understanding the Process
What is FDA 510(k) Clearance?
The FDA 510(k) premarket notification process is the gateway for medical devices to enter the United States market. Named after Section 510(k) of the Food, Drug, and Cosmetic Act, this regulatory pathway requires manufacturers to demonstrate that their device is "substantially equivalent" to a legally marketed predicate device.
Important Distinction: Clearance vs. Approval
510(k) Clearance
For medical devices. Demonstrates substantial equivalence to an existing legal device. Required for moderate-risk devices like LED therapy masks.
FDA Approval
For drugs and high-risk devices (Class III). Requires extensive clinical trials and a Pre-Market Approval (PMA) application. Different process entirely.
To receive 510(k) clearance, the FDA reviews extensive documentation including device specifications, performance testing data, biocompatibility studies, and clinical evidence. This is far more rigorous than simply registering an establishment with the FDA.
Critical Difference
"FDA Cleared" vs. "FDA Registered"
These terms are often confused, but they represent vastly different levels of regulatory scrutiny. Understanding this difference is crucial when evaluating medical devices.
What Verso Has
FDA 510(k) Cleared
- Device-specific regulatory review by FDA
- Safety and efficacy data submitted and evaluated
- Legal permission to make therapeutic claims
- Cleared for specific indications (acne, wrinkles)
- Subject to post-market surveillance
- Manufacturing quality systems audited
The Verso Visage can legally claim to treat acne vulgaris and periorbital wrinkles because the FDA reviewed the evidence and cleared these specific indications.
What Many Competitors Have
FDA Registered (Only)
- Manufacturing facility listed in FDA database
- No device-specific review performed
- No safety or efficacy data required
- Cannot make therapeutic treatment claims
- Essentially a business registration
- Does not verify device quality or performance
"FDA Registered" only means the manufacturer has told the FDA they exist. It provides no assurance about the device's safety or therapeutic value.
The Evidence Standard
What Does Clearance Require?
510(k) clearance is earned through comprehensive documentation and rigorous testing. Here is what manufacturers must provide:
Clinical Testing Data
Device performance must be validated through clinical studies demonstrating safety and intended therapeutic effects on human subjects.
Safety & Efficacy Documentation
Comprehensive technical documentation proving the device performs as intended without presenting unreasonable risks to patients.
Manufacturing Quality Controls
ISO 13485 certified manufacturing processes ensuring consistent product quality and traceability across all production units.
Ongoing Compliance Monitoring
Post-market surveillance requirements including adverse event reporting and periodic facility inspections by FDA officials.
Our Clearance
The Verso Visage Clearance
510(k) Clearance Number
K233114
Device Name
Verso Visage LED Phototherapy Mask
Cleared Indications for Use
- Treatment of acne vulgaris
- Treatment of periorbital wrinkles
Device Classification
Class II Medical Device (Moderate Risk)
Predicate Device
Substantially equivalent to legally marketed LED phototherapy devices for dermatological conditions.
Official FDA Documentation
Clearance documentation available upon request
What This Means for You
Proven Safety
The FDA reviewed safety data and determined the Verso Visage poses no unreasonable risk when used as directed.
Verified Efficacy
Clinical evidence supports the therapeutic claims. This is not marketing speak - it is federally verified performance.
Regulatory Protection
Post-market surveillance and adverse event reporting ensure ongoing safety monitoring by federal regulators.
Buyer Beware
Why Most Competitors Are Not Cleared
The LED light therapy market is flooded with uncleared devices making unsupported claims. Here is why and what to watch for.
Complete Certification
Certified for Global Standards
The Verso Visage meets regulatory requirements across multiple jurisdictions, not just the United States.
FDA 510(k) Cleared
K233114
Cleared for acne vulgaris and periorbital wrinkles
CE Marked
EU MDR 2017/745
European conformity for medical devices
RoHS Compliant
Directive 2011/65/EU
Restriction of hazardous substances
FCC Certified
Part 15 Class B
Electromagnetic compatibility verified
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