04/11/2025
Bluecore Company Secures Taiwan FDA Approval for Its Medical CO₂ Laser “ZenPro”
Bluecore Company Co., Ltd. (Executive Director of Global Business, SEAN YU) announced that the company has recently obtained Taiwan FDA (TFDA) approval for its medical CO₂ laser device, ZenPro.
Taiwan is considered one of the most promising countries in Asia for the growth of advanced medical technologies. With this new regulatory approval, Bluecore Company expects to further strengthen market confidence in ZenPro’s performance, efficacy, and safety across the Asian medical aesthetics sector.
The company views this milestone as a key step in expanding its presence in the Asian medical device market and enhancing its reputation as a trusted manufacturer of high-performance laser systems.
ZenPro is a CO₂ fractional laser system (wavelength approx 10,600 nm) manufactured by Bluecore. Features described:“Fine beam quality” that allows precise treatment of epidermal and dermal layers, with minimal side-effects. Able to reach deeper dermal layers to stimulate collagen remodelling.
Various scanning modes / handpieces: surgical handpiece, fractional scanner, vaginal handpiece for gynecologic indication. Model variants: ZenPro 30 (30 W, RF CO₂ source),
ZenPro 40, (glass tube laser 40W) depending on user needs. Indications listed include aesthetic/resurfacing use (skin rejuvenation, scars), also surgical/gynecologic use (ENT/gynaecologic). Recently cleared by the US FDA via 510(k) path: Device name ZenPro 40
