510(k) Premarket Notification

• Device Classification Name: ophthalmic femtosecond laser
• 510(K) Number: K120426
• Device Name: VICTUS LASER PLATFORM
• Applicant: TECHNOLAS PERFECT VISION GMBH; 1025 sanchez street; san francisco, CA 94114
• Contact: ken nehmer
• Regulation Number: 886.4390
• Classification Product Code: OOE
• Subsequent Product Code: HQF
• Date Received: 02/13/2012
• Decision Date: 07/31/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Ophthalmic
• Review Advisory Committee: Ophthalmic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No