DORNIER MEDILAS D LITEBEAM+ 1470


Device Classification Name

powered laser surgical instrument

510(k) Number K110364
Device Name DORNIER MEDILAS D LITEBEAM+ 1470
Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Applicant Contact john hoffer
Correspondent
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Correspodent Contact john hoffer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/07/2011
Decision Date 12/07/2011
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