Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K121475 |
Device Name |
TXCELL SCANNING LASER DELIVERY SYSTEM |
Applicant |
IRIDEX CORP. |
1212 Terra Bella Ave |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
PAUL H HARDIMAN |
Correspondent |
IRIDEX CORP. |
1212 Terra Bella Ave |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
PAUL H HARDIMAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 11/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|