OPUSDUO EC DENTAL LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K021508
Device Name OPUSDUO EC DENTAL LASER SYSTEM
Original Applicant
OPUSDENT LTD.
117 ahuzah st.
ra’ananna, 

IL

Original Contact dorit winitz
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/09/2002
Decision Date 08/07/2002
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