510(k) Premarket Notification

• Device Classification Name: lenses, soft contact, daily wear
• 510(K) Number: K122220
• Device Name: ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
• Applicant: SOFLEX LIMITED; 33 golden eagle lane; littleton, CO 80127
• Contact: kevin walls
• Regulation Number: 886.5925
• Classification Product Code: LPL
• Date Received: 07/25/2012
• Decision Date: 03/19/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Ophthalmic
• Review Advisory Committee: Ophthalmic
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No