510(k) Premarket Notification

• Device Classification Name: lamp, infrared, therapeutic heating
• 510(K) Number: K122237
• Device Name: BIOPHOTAS LIFELIGHT
• Applicant: BIOPHOTAS, INC.; 28241 crown valley parkway, suite 510(k); laguna niguel, CA 92677
• Contact: shepard g bentley, rac
• Regulation Number: 890.5500
• Classification Product Code: ILY
• Subsequent Product Code: GEX
• Date Received: 07/26/2012
• Decision Date: 01/03/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Physical Medicine
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No