SinoSure Lutronic has announced that its laser medical device, CLARITY II, has recently obtained medical device certifications from the National Medical Products Administration (NMPA) in China and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

This milestone is set to accelerate the company's penetration into the Asian medical and beauty markets, particularly in China and Japan, which are among the largest in the region.

Originally launched in 2019, the CLARITY II system utilizes dual-wavelength laser technology, incorporating Nd:YAG at 1,064 nanometers and Alexandrite laser at 755 nanometers, making it a versatile device for a variety of aesthetic treatments.

Since its debut in 2012, the CLARITY series has established itself as a global bestseller, boasting over 7,000 units sold worldwide by 2025, with a remarkable projection of 1,000 units sold in that single year.

Following its approvals, further sales growth is anticipated as the product gains traction in the Chinese and Japanese markets beginning in 2026.

In February, SinoSure Lutronic secured NMPA approval for the CLARITY II ICD model in China.

This model was sanctioned for wrinkle improvement on facial areas and hair removal operations using the respective 755 nm and 1,064 nm wavelengths.

Concurrently, in January, the company received PMDA approval for the CLARITY II AIR model in Japan, which provides long-lasting hair removal effects through selective thermal action of the laser.

Furthermore, the company is currently undergoing additional modification approval processes for the CLARITY II ICD model in Japan.

China and Japan maintain rigorous regulatory environments for medical devices, often presenting significant barriers for foreign companies seeking to enter these markets.

The recent approvals underscore SinoSure Lutronic's technological capabilities and product competitiveness, marking a significant validation of its standing in key global markets.

CLARITY II has already garnered recognition in major global markets, holding pre-market approval from the U. S.

Food and Drug Administration (FDA) and European CE certification, having reached medical device approval in 39 countries.

Recently, it also obtained label expansion approval from Health Canada, further broadening its application scope in the global market.

In light of its recent approvals in China and Japan, SinoSure Lutronic aims to expedite its expansion plans within the Asian sector.

The company intends to leverage its amassed clinical experience and technological prowess to enhance the market competitiveness of the CLARITY II system, thereby fortifying its position in the global medical aesthetics landscape.

A spokesperson from SinoSure Lutronic stated, “CLARITY II continues to be a popular choice among healthcare professionals and patients for its ability to meet diverse treatment needs.

With the recent approvals in China and Japan, we aim to actively promote the competitiveness of CLARITY II in the Northeast Asian market and strengthen our foothold in the global medical aesthetic sector.”