Tentech Inc. Secures Overseas Certifications for 10THERMA and 10THERA, Enhancing Global Market Reach

  • PublishedMay 20, 2024

Tentech Inc., a global medical device manufacturer, is enhancing the competitive power of its products in the worldwide market.

According to Tentech Inc., it received medical device certification for ‘10THERMA’ from the Medical Device Authority (MDA) of Malaysia on the 13th, followed by certification for ‘10THERA’ from the Therapeutic Goods Administration (TGA) of Australia on the 14th.

10THERMA, with a maximum output of 400W, is a 6.78MHz monopolar radiofrequency (MRF) treatment device. 10THERMA can deliver RF energy to the dermis, generating heat through the skin’s electrical resistance. The 5㎠ face tip is wider than those of other RF devices, allowing for 20% more energy coverage per shot. 10THERMA features an S.T.C. (Smart Temperature Cooling) system, which emits a total of seven cooling pulses during a single shot.

Tentech Inc. has quickly obtained certifications for 10THERMA from global countries such as the United States (U.S. FDA), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), and Thailand (TFDA).

10THERA, using the principle of High Intensity Focused Ultrasound (HIFU), is a HIFU treatment device that delivers ultrasound heat energy to the targeted area. By delivering high heat to the targeted area, typically the SMAS layer or the dermis, it can stimulate the production of collagen. The 10THERA applicator is composed of 2 lines, contributing to a shorter procedure time.

Tentech Inc. has obtained certifications for 10THERA from various oversea countries including Europe (CE), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), Thailand (TFDA), Saudi Arabia (SFDA), and the UAE (MoH).

A representative for Tentech Inc. said, “We recently conducted launch events for products in the countries where certifications for products were approved” and he added, “Tentech’s movements to expand in the global market are expected to result in increased overseas sales this year.”

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