Ilooda, a Kosdaq-listed medical device company specializing in skin aesthetics, said Tuesday that its laser surgical device for skin care, Secret Pro, has received the FDA 510k clearance.
Secret Pro is an upgrade version of the existing laser surgical device, Fraxis Duo, combining a Fractional CO2 laser and a Fractional Needle RF System that minimally invasively applies radiofrequency (RF) through a needle electrode, and is used for removing acne and trauma scars, treating large pores, and lifting skin. Laser Nd Yag Alexandrite
Two new features have been added to Secret Pro, including an upward maximum power when connecting the handpiece to maximize treatment efficiency and a Smart Cure handpiece that delivers RF energy precisely to the local area.
An Ilooda official said that the FDA approval paves the way for further expansion of demand in neighboring countries, mainly in the North American market, and is expected to achieve new results by continuing the success of the Secret family products (Secret, Secret Duo, and Secret Pro), which are gaining market share along with increasing brand awareness in the U.S. market.
As the number of procedures using the micro-needle RF system increases, Ilooda expects that it will also help to improve the company’s operating margin by generating continuous sales of consumables.
"We have a specialized R&D process and infrastructure for medical devices, enabling us to introduce products with the latest technologies quickly," said an Ilooda official. "Based on these capabilities, we will strive to increase sales of products and consumables in the global market."
ipl opt hair removal machine Earlier this month, Ilooda announced that its Secret Family products had surpassed 5,000 units of cumulative global sales this year.