On October 10, 2007, the Life Vessel received a 510(k) clearance from the Food and Drug Administration (FDA) as a Class II medical device.
This clearance provided for the following product information and device description:
FDA 510(k) Number: K070690
Trade / Device Name: Life Vessel
Regulation Number: 21 CFR 890.5500
Regulation Name: Infrared Lamp
Regulation Class: Class II
Product Code: ILY
Dated: October 10, 2007
The Life Vessel is a chamber in which the patient lays flat under the treatment light source and positions the part of the body to be treated under the light source. The system is also used for non-medical relaxation applications and for these purposes includes music and sound components for relaxation.
For further information on FDA medical devices, please visit www.fda.gov/medicaldevices/