Regulatory update
K223033 — Instructions for Use (IFU)
Regulatory update referencing FDA 510(k) K223033 and the associated Instructions for Use (IFU).
Regulatory Updates
Updates and notices relevant to regulatory compliance.
3 items
Regulatory update
510(k) Skin Rejuvenation Clearance
Novoxel announces that Tixel® has received 510(k) clearance for dermatological procedures requiring ablation and resurfacing of the skin.
Regulatory update
510(k) Dry Eye Clearance
Novoxel announces U.S. FDA 510(k) clearance of Tixel i® for application of localized heat and pressure for patients with evaporative dry eye due to MGD.