Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K071328 |
Device Name |
VISUALASE THERMAL THERAPY SYSTEM |
Applicant |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054 -4185
|
|
Applicant Contact |
MATTHEW FOX |
Correspondent |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054 -4185
|
|
Correspondent Contact |
MATTHEW FOX |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/11/2007 |
Decision Date | 08/31/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|