Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K131207 |
Device Name |
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER |
Applicant |
SURGICAL INSTRUMENT ENGINEERING AG |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
SURGICAL INSTRUMENT ENGINEERING AG |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 04/29/2013 |
Decision Date | 10/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|