Tenetech Inc has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for the RF device ‘10THERMA’.
The approval allows the use of 10THERMA in dermatologic and general surgical procedures for electrocoagulation and hemostasis in U.S. It enables dermatologists and plastic surgeons to treat patients using 10THERMA.
With the acquisition of 510(K) clearance from U.S., 10THERMA is expected to hit the streets next month. Tentech Inc. plans to initiate global marketing campaigns for 10THERMA including in a launch event.
According to Tentech Inc., 10THERMA has already surpassed 500 units within the first year. 10THERMA, a 400W monopolar RF device with a 5㎠ tip size, boasts a treatment area 25% larger than other monopolar devices. Additionally, 10THERMA can deliver 20% more heat energy.

“10THERMA, which creates high heat to regenerates collagen in dermis in a non-invasive way, showed a significant effect on skin tightening and improvement of wrinkles when compared other RF devices in a study,” said Mr. Han, CEO of Tentech Inc. he added “10THERMA is gaining popularity worldwide and is rapidly getting market share.”
Meanwhile, Tentech Inc. has entered export contracts for 10THERMA with distributors in 11 Countries such as U.S., Brazil, Taiwan, Singapore and others.