Device Classification Name |
Ophthalmic Femtosecond Laser
|
510(k) Number |
K122386 |
Device Name |
VICTUS FEMTOSECOND LASER PLATFORM |
Applicant |
TECHNOLAS PERFECT VISION GMBH |
PO BOX 17190 |
ANAHEIM,
CA
92817 -7190
|
|
Applicant Contact |
BETTY M JOHNSON |
Correspondent |
TECHNOLAS PERFECT VISION GMBH |
PO BOX 17190 |
ANAHEIM,
CA
92817 -7190
|
|
Correspondent Contact |
BETTY M JOHNSON |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/2012 |
Decision Date | 02/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|