The FDA has approved Biolase Technology's (San Clemente, CA)Millennium Hydrokinetic YSGG dental laser for use with children. The FDA clearance covers procedures including caries removal, hard tissue surface roughening or etching, and soft tissue surgical procedures, the firm says.
"Clearance to market our multi-purpose technology for pediatric dentistry differentiates the Millennium from other laser-based dental systems, underscores its safety and comfort, and dramatically increases its market potential," said Jeffrey Jones, president and CEO of Biolase Technology.
Jones pointed out that revenues for the most recent quarter, ended March 31, were greater than total revenues for all of 1998 and the company hopes to be profitable in the first quarter of 2000. The company reported sales for the first quarter of 1999 of over $1.7 million. This level, it says, represents a 580% increase over the same period in 1998.
"We are targeting sales of more than $10 million in 1999, representing sales of about 250 units, and we are optimistic that the latest FDA clearance will contribute to that growth," Jones added.
The company says it will soon make available for the public a web site that will direct them to locations of "pain-free dentists."