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: MEDITEC OPL3 ND:YAG LASER
• Generic Name: Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: Medical Laser, Inc.; 5454 Wisconsin Ave.; Chevy Chase, MD 20815
• PMA Number: P830025
• Supplement Number: S001
• Date Received: 02/22/1985
• Decision Date: 06/25/1985
• Product Code: LOI
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No