Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K082809 |
Device Name |
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
Applicant |
LUMENIS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Applicant Contact |
FRANCES E HARRISON |
Correspondent |
LUMENIS, INC. |
3959 WEST 1820 SOUTH |
SALT LAKE CITY,
UT
84104
|
|
Correspondent Contact |
FRANCES E HARRISON |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/24/2008 |
Decision Date | 12/18/2008 |
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
|