Tentech obtains medical device approval for IPL equipment '10PL' from Australia's TGA

Tentech obtains medical device approval for IPL equipment '10PL' from Australia's TGA

Medical device manufacturer Tentech announced on the 23rd that it has completed medical device approval for its pulsed light irradiation (IPL) device '10PL' from the Australian Therapeutic Goods Administration (TGA).

An official from Tentech explained, “In addition to the TGA, 10PL is a medical device that has obtained overseas certification for major countries such as the United States and Europe, and the safety and effectiveness of the product are recognized globally in overseas markets.”

10PL passes the strong output light generated from the At this time, the photomechanical effect occurring in the skin and the photothermal effect that converts absorbed light energy into heat energy are utilized.

This official said, "10PL emits photons in the form of pulses using a wide wavelength range of 450~950nm, which is more effectively absorbed by melanin, etc., so it causes selective thermal damage to the target without damaging surrounding tissues, preventing skin diseases.

In addition to 10PL, Tentech also owns its core product, 10THERMA, a monopolar high-frequency medical device. This device has obtained certification from the US FDA and overseas certification from national regulatory agencies such as Taiwan's TFDA, Thailand's TFDA, and Indonesia's MoH.

In addition, the High Intensity Focused Ultrasound (HIFU) medical device ‘10THERA’ has acquired overseas certifications such as Europe’s CE, Taiwan’s TFDA, Thailand’s TFDA, Saudi Arabia’s SFDA, and UAE’s MoH and is actively being exported.

The company hopes that as its major products have successively obtained overseas certification, a green light has been given to expand its global market channels.

Dong Ok Han, CEO of Tentech, said, “The fact that medical devices such as 10THERMA and 10PL are certified by various organizations, including the U.S. FDA, is an important factor proving that Tentech has excellent technology.” He added, “The development of these new markets will increase Tentech’s overseas sales in the future.” “It will lead to an increase in the proportion,” he explained.

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