Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL
• Classification Name: intraocular lens
• Generic Name: posterior chamber intraocular lenses
• Regulation Number: 886.3600
• Applicant: CHIRON VISION CORP.
• PMA Number: P910061
• Supplement Number: S001
• Date Received: 06/10/1997
• Decision Date: 10/21/1997
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the models li51u and li61u iols.