INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS


Device Classification Name

powered laser surgical instrument

510(k) Number K023182
Device Name INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
Original Applicant
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Original Contact carol sprinkle
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/24/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No