Alma Hybrid Laser Receives FDA 510(k) Clearance

Alma, a Sisram Medical Company, today announced the FDA 510(k) clearance of its Alma Hybrid laser.¹ This laser platform is the first to include an ablative 10,600 nm (CO2) laser and nonablative 1570 nm laser for skin resurfacing, according to a press release announcing the approval. This allows physicians to select customized treatment patterns by combining both wavelengths. 

Alma hybrid aims to decrease downtime for patients while also heightening the results of treatment by combining ablative CO2 injury with non-ablative 1570 nm injury, known as a HyGrid method. 

This introduces a previously unseen injury pattern when compared with other available devices on the market. 

The process of combining the ablative CO2 laser and nonablative 1570 nm laser, according to Jeffrey Hsu, MD, a dermatologist at Oak Dermatology, Itasca, Illinois, helps him do skin resurfacing treatments in 15 minutes by using HyPer delivery. This high performance delivery is categorized as ablative CO2 injury followed by nonablative 1570 nm injury in random pattern, which, according to the company, significantly reduces treatment time and improves patient experience. 

"Alma has a long-established track record of developing radically innovative solutions such as Alma Hybrid to the market," said Keith Adams, president of Alma North America, Cincinnati, Ohio, in the release. "We're committed in advancing our industry forward by investing in essential treatment categories that our customers and their patients depend on, like skin resurfacing."

Reference:

1. Alma, a Sisram medical company, announces FDA clearance and the U.S. launch of Alma Hybrid. Cision PR Newswire. July 20, 2021. Accessed July 20, 2021. https://www.prnewswire.com/news-releases/alma-a-sisram-medical-company-announces-fda-clearance-and-the-us-launch-of-alma-hybrid-301337238.html