|
Device | TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S017 |
Date Received | 04/26/2012 |
Decision Date | 01/18/2013 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE SOURCE TO PRODUCE THE THYRATRON POWER SUPPLY AND LASER HEAD ASSEMBLIES. |