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10PL ,IPL Fractional Medical Device, Approved by TGA of Australia

  • PublishedApril 26, 2024

Tentech Inc., a global medical device manufacturer, announced on Tuesday that ’10PL’ ,IPL (Intense pulsed light) fractional medical Device, approved by the Therapeutic Goods Administration(TGA) of Australia.
According to Tentech Inc., “10PL already obtained other certifications for major countries such as the United States (FDA) and Europe (CE) for its medical devices. In a word, These certifications present that 10PL is globally recognized for its safety and efficacy of the product on the international market.”

10PL uses a Xenon Lamp to produce intense light output, which is then filtered through specific wavelengths to deliver short pulses of light onto the skin. In this process, it uses the photomechanical effects occurring on the skin, converting absorbed light energy into heat energy.

The representative for Tentech Inc. explained, “10PL emits light in pulse form over a wide wavelength range of 450 to 950nm, effectively targeting substances like melanin. Therefore, 10PL can improve skin conditions by heating only targeted areas without causing damage to surrounding tissues.”

Meanwhile, 10THERMA, monopolar RF device (main device) of Tentech inc., holds FDA certificate (U.S.510(k) clearance), TFDA certificate (Taiwan), TFDA certificate (Thailand), and MoH certificate (Indonesia) and so on.

Moreover, Tentech Inc. ‘s another main device 10THERA, ‘2 Line irradiating’, HIFU treatment, holds CE certificate(EU),TFDA certificate (Taiwan),TFDA certificate (Thailand),MoH certificate (UAE), SFDA certificate (Saudi),MoH certificate (Indonesia), MoH certificate (Vietnam), and so on.

Mr. Han, the CEO of Tentech Inc., stated, “Certifications of our medical devices such as 10THERMA and 10PL by various institutions including the U.S. FDA is an important factor demonstrating Tentech’s excellent technologies.” He added, “We expect that pioneering new markets will lead to an increase in Tentech’s overseas sales in the future.”

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