LAMEDITECH Co., Ltd. Applies for MFDS Approval for New Laser Medical Device ‘FX-7000M’… Aims for Second-Half Launch
Incorporating ‘Laser Micro-Channeling’ Technology to Reduce Pain and Recovery Burden
Skinbooster’s Diversification Strategy... Also Begins MFDS Approval Process
[E-Daily YU JIN-HEE Reporter] LAMEDITECH Co., Ltd.(462510), a company specializing in laser medical and cosmetic devices, is stepping up its efforts to enter the high-growth skin booster aesthetics market by initiating the approval process for a new product intended for use in hospitals and clinics.
LAMEDITECH Co., Ltd.(462510)The company announced on the 7th that it has applied to the Ministry of Food and Drug Safety for a medical device manufacturing license for the “FX-7000M,” a new laser medical device designed for use in hospitals and clinics. The company plans to officially launch the product in the domestic market in the second half of this year as soon as the approval process is finalized, aiming to secure a new growth engine.
(Photo: LAMEDITECH Co., Ltd.)
The FX-7000M, for which the company has applied for approval, is a new product designed specifically for clinical environments in hospitals and clinics, incorporating LAMEDITECH Co., Ltd.’s proprietary laser technology and extensive experience in medical device development accumulated over many years. It combines precise output performance that meets medical device standards with ease of use, and has been developed as a laser platform that can be widely customized to suit various medical aesthetic treatment purposes.
Recently, in both domestic and international aesthetic medicine markets, demand has been rising sharply for procedures that improve the overall skin condition, including “skin boosters” that directly inject active ingredients into the skin. Consequently, there is a growing trend toward laser equipment that can be widely utilized by individual medical institutions.
In line with these market trends, LAMEDITECH Co., Ltd. has introduced “Laser Micro-Channeling” technology to the FX-7000M, which dramatically reduces pain during procedures and accelerates the return to daily activities after treatment. This method temporarily creates microscopic channels on the skin’s surface to maximize the penetration rate of active ingredients. The company plans to launch a full-scale marketing campaign focused on its network of major hospitals and clinics nationwide once approval from the Ministry of Food and Drug Safety is finalized.
The FX-7000M’s key differentiator is that, in addition to its core laser platform functions, it is designed to be used in conjunction with extracellular matrix (ECM)-based aesthetic solutions—a new growth engine the company is actively pursuing. By first creating channels in the skin barrier through laser treatment and then introducing active ingredients from ECM biomaterials, drug delivery efficiency is doubled, maximizing clinical synergy.
Previously, in May, LAMEDITECH Co., Ltd. secured a license from the Ministry of Food and Drug Safety to establish a human tissue bank, thereby laying the foundation for its extracellular matrix regenerative medicine materials business. With the launch of this new device, the company aims to firmly establish a differentiated medical aesthetics portfolio that integrates “laser drug delivery system” (DDS) equipment with “biomaterials.”
A LAMEDITECH Co., Ltd. official emphasized, “The FX-7000M is a strategic model designed to proactively address the demand in the rapidly growing aesthetic market centered on hospitals and clinics,” adding, “Using its commercial launch in Korea in the second half of the year as a springboard, we will expand our market share into various medical aesthetic treatment settings while further strengthening our global business competitiveness as a medical tech company based on our differentiated laser technology.”
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