POLRIS LV


Device Classification Name

powered laser surgical instrument

510(k) Number K030186
Device Name POLRIS LV
Original Applicant
SYNERON MEDICAL LTD.
pob 550
yokneam elite, 

IL

20692

Original Contact amir waldman
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/21/2003
Decision Date 04/14/2003
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