Why FDA Clearance Matters — And Why We Chose the Stellar M22 by Lumenis
When it comes to your skin, safety and real results matter. That’s why at Naked., we use the Stellar M22 by Lumenis, a globally trusted, FDA-cleared aesthetic laser platform. Whether you’re seeking skin rejuvenation, vascular treatment, or laser hair removal, knowing your treatment is approved and evidence-based provides peace of mind.
What Does “FDA-Cleared” Actually Mean?
In the U.S., the Food and Drug Administration (FDA) regulates medical devices to ensure they are safe and effective. When a laser is FDA-cleared, it means it has undergone rigorous testing and has been proven equivalent in safety and efficacy to other legally marketed devices.
🔗 Learn more about FDA clearance
This clearance is not just a label—it’s an assurance of quality and safety. Many devices in the aesthetics market are not FDA-cleared, meaning their claims and performance have not been verified at this level.
The Global Recognition of Stellar M22
The Lumenis Stellar M22 isn’t just FDA-cleared—it’s also approved and trusted worldwide, making it one of the most clinically validated and versatile laser platforms available.
🌍 Globally cleared and trusted by:
The FDA in the U.S.
The CE mark in the European Union
Health Canada
Regulatory agencies in over 90 countries
🔗 Lumenis Official Stellar M22 Overview
🔗 CE Mark for Medical Devices – European Commission
🔗 Health Canada Medical Devices Licensing
What Makes the Stellar M22 Unique?
Unlike single-function lasers, the Stellar M22 offers four powerful technologies in one platform:
IPL (Intense Pulsed Light) – treats sun damage, pigmentation, redness, and more
Nd:YAG Laser – targets deeper vascular conditions like leg veins
Multi-Spot™ Nd:YAG – precise treatment for deeper vessels
These are clinically proven technologies supported by peer-reviewed research, including:
🔗 Fractional nonablative laser resurfacing: Review of clinical studies
🔗 IPL treatment for rosacea and vascular lesions
🔗 Nd:YAG lasers in aesthetic dermatology
Why We Trust the Stellar M22 at Naked.
At Naked., our priority is giving clients advanced, results-driven care without compromising safety. The Stellar M22 allows us to treat a wide range of skin types and concerns with customizable settings and minimal downtime, which means:
Better outcomes
Safer treatments for all skin tones
Confidence that you’re receiving science-backed care
And because it’s FDA-cleared and used by top clinics worldwide, we know you’re getting the best available.
Bottom Line: Trust the Science, Not the Hype
In an industry flooded with trendy devices and flashy marketing, we stay grounded in science, safety, and proven results. The Stellar M22 by Lumenis meets the highest standards globally and gives us the ability to treat skin with precision and confidence.
Ready to find out how it can work for you?
