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: NEODYMIUM-YAG OP LASER OPL-3
• Generic Name: Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla
• Regulation Number: 886.4392
• Applicant: Coburn Optical Ind., Inc.; Proffessional Products Div.; P.O. Box 2498; Clearwater, FL 33517
• PMA Number: P830064
• Supplement Number: S002
• Date Received: 11/07/1984
• Decision Date: 12/13/1984
• Product Code: LXS
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No