main contents menu area
Press Center
The Newest Updates on Hironic

News

  • TitleHironic, skin acne treatment equipment AFit US FDA approval
  • Hit9,752
  • Date18-09-17 20:25

1a6506fa8a7b9a6b4eee52495e62e9ac_1537264 

 

Hironic, a medical device manufacturer specializing in skin care, announced on the 15th that Afit, an acne treatment equipment that combines 1450nm laser and RF, has obtained FDA and got a permission to sell in USA.

Afit has increased its competitive edge by adding RF to a laser with 1450nm diode laser-based equipment that is highly absorbent with oil and moisture and can penetrate into the dermis layer.

RF coupling with 1450nm laser

Main handpiece is laser alone

In addition, the CCD (Cryogen Cooling Device) is sprayed before laser irradiation to cool and protect the epidermis to reduce pain and protect the skin.

For the first time, a 1450nm laser, RF, and CCD were combined into a single hand piece. Afit is implemented with Hironic's patented proprietary technology.

The use of individual RF handpieces increases pain relief by increasing circulation in the area. Afit has the advantage of being able to use laser and RF synergy in one device, so it can be used for various indications.

Hironic has established a decisive moment to expand the global market due to the FDA approval of Afit equipment following CE certification of the existing equipment such as Double gold and MI-COOL.

 "Afit's FDA approval has a great significance in that it has established a bridge for entry into the United States, which is the largest market in the global cosmetic medical device, with a share of nearly 50%," said the CEO of Hironic, Jinwoo Lee. "Other equipments that are under FDA approval will also be affected." he added.

On the other hand, Hironic, which has increased its market share in Europe and Asia, is expected to make a breakthrough in the US market with Afit's FDA approval.


-Money Today-


 

 

 

 



 

  • URL
  • File (0)
하이로닉 로고

하이로닉 영문 웹사이트로 이동합니다.
글로벌 웹사이트에는 수출용 제품으로
대한민국에서 허가하지 않은 장비 및 서비스
내용을 포함하고 있습니다. 해당 내용은
대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.

영문 웹사이트 →

It goes to the HIRONIC English website.
The Global Web Site contains equipment
and services that are not authorized by
the Republic of Korea These contents
are not subject to review and regulation
of medical devices in Korea.

English Website →
닫기
하이로닉 로고

하이로닉 EU 웹사이트로 이동합니다.
EU(Europe) 웹사이트의 내용은 "CE MDD 또는 CE MDR" 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.

EU 웹사이트 →

It goes to the HIRONIC EU website.
The contents of the EU(European) web page are about product information of items approved for "CEMDD or CEMDR" in EU countries. They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.

EU Website →
닫기
하이로닉 로고

하이로닉 중국어 웹사이트로 이동합니다.
중국어 웹사이트에는 중국내 판매제품으로
대한민국에서 허가하지 않은 장비 및 서비스
내용을 포함하고 있습니다. 해당 내용은
대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.

중국어 웹사이트 →

正在移动到HIRONIC的中文官网。
在中问官网内介绍的产品只在中国销售的产品,
不一定是在韩国得到认可和服务内容。
针对这内容没有受到韩国医疗仪器广告审议限制。

中文官网 →
닫기