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It goes to the HIRONIC INTL. website.
The Intrrnation 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.
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It goes to the HIRONIC US website.
The contents of the US web page are about product information of items approved for "FDA". They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.
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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.
Hironic Inc. (CEO: Jinwoo Lee) announced on August 21 that it has received official medical device sales approval from the Taiwan Food and Drug Administration (TFDA) for its integrated lifting system ‘New Doublo 2.0’. The company also confirmed that Collamatrix, a top-tier distributor in Taiwan, will serve as its exclusive partner in the region.
The aesthetic medical device industry is currently experiencing rapid growth driven by technological convergence and increasing preference for non-invasive procedures. According to global market research, the global aesthetic medicine market is expected to reach USD 71.62 billion by 2025, with a CAGR of 7.75%.
Taiwan’s market is also expanding steadily due to its aging population and evolving beauty trends. Industry analysts forecast the Taiwanese beauty and personal care market to reach approximately USD 5.7 billion by 2027.
Hironic’s expansion into Taiwan is backed by growing regional demand for advanced hybrid technologies such as HIFU (High-Intensity Focused Ultrasound) and RF (Radio Frequency).
The ‘New Doublo 2.0’ combines HIFU, RF, and microneedling capabilities, offering powerful lifting results with shorter treatment time and minimal recovery burden. Taiwanese dermatologists who attended the 2024 Taiwan Symposium highlighted the device’s “multi-layer treatment advantage” and anticipated broad patient adoption.
Hironic views this regulatory milestone not merely as a sales license, but as a significant example of how K-Beauty is extending beyond cosmetics into high-value medical aesthetics. The company believes the Korean aesthetic medical device sector is proving its global competitiveness in both technology and compliance.
“Hironic aims to elevate its brand value in Taiwan to the highest tier,” said Sungho Lee, Chief Marketing Officer at Hironic. “We expect the standardization and global brand power of Korean medical aesthetic devices to grow even stronger in the coming years.”
