Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Alcon Laboratories; R; Van Nuys, CA 30348
• PMA Number: P830034
• Supplement Number: S022
• Date Received: 06/13/1990
• Decision Date: 08/06/1992
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No