|
Device | VISUMAX FEMTOSECOND LASER SYSTEM |
Generic Name | Femtosecond laser system for refractive correction |
Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
PMA Number | P150040 |
Supplement Number | S001 |
Date Received | 01/06/2017 |
Decision Date | 02/28/2017 |
Product Code |
OTL |
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 software changes. |