Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K053087 |
Device Name |
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM |
Applicant |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054
|
|
Applicant Contact |
ASHOK GOWDA |
Correspondent |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054
|
|
Correspondent Contact |
ASHOK GOWDA |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/02/2005 |
Decision Date | 03/01/2006 |
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
|
Recalls |
CDRH Recalls
|