Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K081219 |
Device Name |
APOLLO MINI IPL SYSTEM |
Applicant |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
102 OXMOOR RD. |
SUITE 13 |
HOMEWOOD,
AL
35209
|
|
Applicant Contact |
MARK ROHRER |
Correspondent |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
102 OXMOOR RD. |
SUITE 13 |
HOMEWOOD,
AL
35209
|
|
Correspondent Contact |
MARK ROHRER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/30/2008 |
Decision Date | 06/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|