FOTONA DUALIS PLUS ND:YAG LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K022839
Device Name FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
Original Applicant
FOTONA D.D.
stegne 7,
ljubljana, 

SI

1210

Original Contact mojca valjavec
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/27/2002
Decision Date 11/25/2002
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