MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM


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

Correspodent Contact philippe amar
Regulation Number 878.4810
Classification Product Code
ONF  
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