The Harmony XL Pro and its iPixel Er:YAG module are backed by rigorous clinical testing and international medical certifications, ensuring the highest standards of patient safety.
- FDA Cleared: The Pixel 2940nm technology received US Food & Drug Administration (FDA) clearance in 2006 specifically for fractional ablative laser skin resurfacing.
- CE Marked: The system was awarded the European CE Mark in September 2006, certifying it meets all EU safety, health, and environmental protection requirements.
- Clinically Proven: The Harmony XL platform is used globally and is cleared for over 65 medical and aesthetic indications, making it one of the most versatile and trusted systems in the industry.
- Doctor-Led Safety: At Cosmedics Skin Clinics, all iPixel treatments are performed by Aesthetic Doctors. We perform a mandatory medical consultation and skin patch test 48 hours before treatment to ensure complete skin suitability.