Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K112031 |
Device Name |
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION |
Applicant |
ALMA LASERS, INC. |
485 HALF DAY RD. |
SUITE NO. 100 |
BUFFALO GROVE,
IL
60089
|
|
Applicant Contact |
ANNE WORDEN |
Correspondent |
ALMA LASERS, INC. |
485 HALF DAY RD. |
SUITE NO. 100 |
BUFFALO GROVE,
IL
60089
|
|
Correspondent Contact |
ANNE WORDEN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/15/2011 |
Decision Date | 09/13/2011 |
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
|