FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K050293
Device Name FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
Applicant
FOTONA D.D.
stegne 7,
ljubljana, 

SI

1210

Applicant Contact stojan trost
Correspondent
FOTONA D.D.
stegne 7,
ljubljana, 

SI

1210

Correspodent Contact stojan trost
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/07/2005
Decision Date 03/18/2005
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