|
Device | TECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S003 |
Date Received | 04/27/2001 |
Decision Date | 09/25/2001 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD AN ACTIVE EYETRACKER AS AN ACCESSORY TO THE LASER SYSTEM. |