Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K082825 |
Device Name |
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM |
Applicant |
ENERGIST, LTD. |
2 CLOS LLYN CWM |
ENTERPRISE PARK |
SWANSEA,
GB
SA6 8QY
|
|
Applicant Contact |
TIM MAJOR |
Correspondent |
ENERGIST, LTD. |
2 CLOS LLYN CWM |
ENTERPRISE PARK |
SWANSEA,
GB
SA6 8QY
|
|
Correspondent Contact |
TIM MAJOR |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/25/2008 |
Decision Date | 02/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|