All Biolase products presented are class II medical devices regulated by US Food and Drug Administration (FDA). All information presented here that is not limited to the current FDA clearance for the device is not supported by Biolase. The FDA has cleared the Biolase devices for specific intended use and indications for use.
Such information is available to you through brochures, user manuals, website information and all other printed and displayed materials provided by Biolase. Use of the Biolase products outside of the cleared indications for use is considered investigational by the FDA. The agency does not allow manufacturers to promote and/or sell investigational products that have not been cleared by the FDA.