[Asia Economy Reporter Hyungsoo Park] Global medical device specialist Iruda announced on the 27th through a public disclosure that it has upgraded the laser part of the combined treatment device ‘Secret Duo’ and obtained approval from the U.S. Food and Drug Administration (FDA).
‘Secret Duo’ is a product that combines a 1540nm wavelength laser system and a microneedle RF (radio frequency) system, enabling complex procedures. The microneedle RF delivers thermal energy to the lower dermis area, while the 1540nm wavelength laser targets the upper dermis area, allowing for safer and more diverse treatments.
Iruda previously received 510K (pre-market approval) from the FDA on the 13th for the high-frequency electrosurgical device Acutron™ and its dedicated electrode. Following the FDA approval of the microneedle RF system of ‘Secret Duo’ in April last year, the company has demonstrated its technological capabilities by obtaining additional approval through the laser system upgrade this time.
With the FDA approval of ‘Secret Duo,’ Iruda can strengthen its responsiveness to the increasing demand for combined medical devices in the market and create an opportunity to supply high value-added products to the U.S. market compared to standalone devices. This is also expected to contribute to Iruda’s performance improvement. As procedures using the microneedle RF system increase, continuous consumable sales are expected to help boost revenue and improve operating profit margins.
An Iruda official stated, "With the U.S. FDA certification of Secret Duo, along with the existing high-frequency electrosurgical device Secret RF and combined medical device Secret Pro, we expect to contribute to expanding market share by strengthening brand awareness in the U.S., the largest market for dermatological aesthetic medical devices."
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