OPTILITE HOLMIUM LASER FIBERS


Device Classification Name

powered laser surgical instrument

510(k) Number K073496
Device Name OPTILITE HOLMIUM LASER FIBERS
Applicant
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Applicant Contact cindy foote
Correspondent
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer, 
IN 
47460

Correspodent Contact cindy foote
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/12/2007
Decision Date 01/23/2008
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