Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K103501 |
Device Name |
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES |
Applicant |
ALMA LASERS, INC. |
485 HALF DAY RD. |
SUITE #100 |
BUFFALO GROVE,
IL
60089
|
|
Applicant Contact |
TATIANA EPSTEIN |
Correspondent |
ALMA LASERS, INC. |
485 HALF DAY RD. |
SUITE #100 |
BUFFALO GROVE,
IL
60089
|
|
Correspondent Contact |
TATIANA EPSTEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/29/2010 |
Decision Date | 01/14/2011 |
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
|