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-CLEAN(TM) LC 1323
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Alcon Laboratories; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P820036
• Supplement Number: S005
• Date Received: 07/19/1985
• Decision Date: 10/16/1986
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No