MEDART DIODE LASER SYSTEM & ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K110243
Device Name MEDART DIODE LASER SYSTEM & ACCESSORIES
Applicant
MEDART A/S
clos llyn cwm
swansea, wales, 

GB

sa6 8qy

Applicant Contact joanne davies
Correspondent
MEDART A/S
clos llyn cwm
swansea, wales, 

GB

sa6 8qy

Correspodent Contact joanne davies
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/27/2011
Decision Date 06/28/2011
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