DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K021724
Device Name DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
Original Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw, 
GA 
30144

Original Contact tim thomas
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/24/2002
Decision Date 08/19/2002
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