Biolase Laser Receives FDA OK for First Nondental Surgery
IRVINE, Calif., May 9, 2013 — Dental laser maker Biolase Inc.'s WaterLase iPlus all-tissue laser has been cleared by the US Food and Drug Administration for soft-tissue use in orthopedic and podiatric surgery, the company announced Wednesday. It is the first nondental clearance for its flagship product.
Biolase Chairman and CEO Federico Pignatelli said the approval expands the product into two markets, each with tremendous potential. "Just the top ten orthopedic surgical soft-tissue procedures, for example, offer a $2.6 billion market opportunity for our WaterLase technology."
The iPlus was cleared for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and noncontact with tissue, in orthopedic and podiatric surgery, including soft and cartilaginous tissue in small and large joints.
"During the past several years, the use of lasers in orthopedic surgery has become more accepted as a less-invasive alternative to conventional surgery, and it has become clear that modern lasers will play a significant role in the treatment of musculoskeletal injuries," said Dr. Amado Carino, the company's global clinical affairs manager.
For more information, visit: www.biolase.com