510(k) Premarket Notification

• Device Classification Name: confocal optical imaging
• 510(K) Number: K122042
• Models: ALVEOFLEX, ALVEOFLEX M, F-400,F-400 V2, GASTROFLEX, GASTROFLEX UHD, GASTROFLEX M, COLOFLEX, COLOFLEX UHD
• Device Name: CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
• Applicant: MAUNA KEA TECHNOLOGIES; 8 snowberry court; orinda, CA 94563
• Contact: michael daniel
• Regulation Number: 876.1500
• Classification Product Code: OWN
• Date Received: 07/12/2012
• Decision Date: 09/04/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General & Plastic Surgery
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No