Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K051944 |
Device Name |
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES |
Applicant |
LUMENIS, INC. |
2400 CONDENSA ST. |
SANTA CLARA,
CA
95051 -0901
|
|
Applicant Contact |
KAREN L BAKER |
Correspondent |
LUMENIS, INC. |
2400 CONDENSA ST. |
SANTA CLARA,
CA
95051 -0901
|
|
Correspondent Contact |
KAREN L BAKER |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/18/2005 |
Decision Date | 09/30/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|