UltraClear fiber laser earns FDA clearance in two expanded indications

Key takeaways:

• The FDA cleared the expanded indication of the UltraClear cold ablative fractional 2,910 nm fiber laser.
• The expanded use includes the treatment of benign pigmented lesions and vascular dyschromia.

The FDA has approved the expanded use of the UltraClear cold ablative fractional 2,910 nm fiber laser for the treatment of benign pigmented lesions and vascular dyschromia, Acclaro Medical announced in a press release.

“This clearance underpins our commitment to addressing the unmet needs of patients living with pigmentation disorders by improving upon the current treatment paradigm of acids, peels and passé devices,” Shlomo Assa, co-founder and president, chief technology officer, Acclaro Medical, said in the release.

According to the press release announcing its launch in April 2022, UltraClear’s 2,910 nm wavelength is at water peak absorption, allowing it to maximize tissue ablation while minimizing the incidence of post-inflammatory hyperpigmentation, erythema and bleeding.

The company has announced that results on UltraClear’s performance in treating cosmetic skin conditions, including aging, facial wrinkles, pigmentation and scars, will be presented at the Symposium for Cosmetic Advances & Laser Education.

Reference:

• World’s first FDA approved cold ablative fiber laser makes US debut. https://www.prnewswire.com/news-releases/worlds-first-fda-approved-cold-ablative-fiber-laser-makes-us-debut-301534988.html. Published April 28, 2022. Accessed May 15, 2024.