FOTONA NOVALIS ER: YAG LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K991632
Device Name FOTONA NOVALIS ER: YAG LASER SYSTEM
Applicant
FOTONA D.D.
stegne 7,
ljubljana, 

SI

1210

Applicant Contact mojca valijavec
Correspondent
FOTONA D.D.
stegne 7,
ljubljana, 

SI

1210

Correspodent Contact mojca valijavec
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/12/1999
Decision Date 08/10/1999
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