Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K111350 |
Device Name |
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM |
Applicant |
MEDICAM INC. |
7900 JEAN-BRILLON |
MONTREAL, QUEBEC,
CA
H8N 2L5
|
|
Applicant Contact |
PHILIPPE AMAR |
Correspondent |
MEDICAM INC. |
7900 JEAN-BRILLON |
MONTREAL, QUEBEC,
CA
H8N 2L5
|
|
Correspondent Contact |
PHILIPPE AMAR |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/13/2011 |
Decision Date | 09/29/2011 |
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
|