Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K082407 |
Device Name |
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM |
Applicant |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
105 CITATION COURT |
HOMEWOOD,
AL
35209
|
|
Applicant Contact |
MARK ROHRER |
Correspondent |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
105 CITATION COURT |
HOMEWOOD,
AL
35209
|
|
Correspondent Contact |
MARK ROHRER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/21/2008 |
Decision Date | 02/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|