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: S002
• Date Received: 11/28/1986
• Decision Date: 01/09/1987
• Reclassified Date: 03/31/1988
• Product Code: LOI
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No