Ra Medical Systems Gets 510(k) Clearance for Laser Ablation Systems

Ra Medical Systems has received 510(k) clearance from the FDA for two new DABRA (destruction of arteriosclerotic blockages by laser-radiation ablation) devices.

The clearance covers the Carlsbad, Calif.-based company’s DABRA Laser Model RA-308 and DABRA Catheter Model 101.

The excimer laser, which emits very concentrated ultraviolet light, and the single-use catheter system are used for removal of blockages resulting from lower extremity vascular disease. The laser system can also be used to clear chronic skin conditions.