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: CILCO ND:YAG LASER
• Generic Name: Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: Coopervision-Cilco; 1616 13th Ave., Huntington, W.; Va
• PMA Number: P840047
• Supplement Number: S001
• Date Received: 09/06/1985
• Decision Date: 11/26/1985
• Reclassified Date: 03/31/1988
• Product Code: LOI
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No