Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K083272 |
Device Name |
SKINCLEAR Q-SWITCHED ND:YAG LASER |
Applicant |
GLOBAL USA DISTRIBUTION, LLC. |
10723 AQUILA AV. S. |
MINNEAPOLIS,
MN
55438
|
|
Applicant Contact |
MATT MAKOUSKY |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/06/2008 |
Decision Date | 12/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|