Global energy-based medical device (EBD) company Biolmedical announced on Thursday that its products, Scarlet Pro and SB-49TIP, have received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Scarlet Pro, a micro-needle radiofrequency (RF) medical device, is designed to deliver thermal energy with adjustable treatment depth.
The SB-49TIP offers a larger treatment area compared to existing consumable tips, improving treatment efficiency and reducing procedure time.
With this FDA 510(k) approval, Biolmedical aims to strengthen its presence in the U.S. market and expand its global reach.
The company has already secured regulatory approvals in key Asian countries and is now extending its footprint into Europe, the Middle East, and Southeast Asia.
Biolmedical specializes in energy-based medical devices (EBD) utilizing RF and micro-needle technology, focusing primarily on dermatology and aesthetic medicine. The company has established its competitive edge through its flagship ‘Scarlet’ series, which showcases its micro-needle RF technology. Biolmedical has been expanding its business to serve both domestic and international medical institutions.