Device Classification Name |
ophthalmic femtosecond laser
|
510(k) Number |
K120426 |
Device Name |
VICTUS LASER PLATFORM |
Applicant |
TECHNOLAS PERFECT VISION GMBH |
1025 SANCHEZ STREET |
SAN FRANCISCO,
CA
94114
|
|
Applicant Contact |
KEN NEHMER |
Correspondent |
TECHNOLAS PERFECT VISION GMBH |
1025 SANCHEZ STREET |
SAN FRANCISCO,
CA
94114
|
|
Correspondent Contact |
KEN NEHMER |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/13/2012 |
Decision Date | 07/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|