Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K081704 |
Device Name |
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS |
Applicant |
LUMENIS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
TINA MAYER |
Correspondent |
LUMENIS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
TINA MAYER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/17/2008 |
Decision Date | 09/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|