FOTONA TANDEM LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K022837
Device Name FOTONA TANDEM 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