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: SOF!PRO-CLEAN CONTACT LENS CLEANER
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Lobob Laboratories, Inc.; 1440 Atteberry Ln.; San Jose, CA 95131
• PMA Number: P810041
• Supplement Number: S003
• Date Received: 12/07/1983
• Decision Date: 06/04/1984
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No