AURORA SR


Device Classification Name

powered laser surgical instrument

510(k) Number K022266
Device Name AURORA SR
Original Applicant
SYNERON MEDICAL LTD.
pob 550
yokneam elite, 

IL

20692

Original Contact amir waldman
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
GEI  
Date Received 07/12/2002
Decision Date 10/03/2002
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