YOULASER CO2 LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K111592
Device Name YOULASER CO2 LASER SYSTEM
Applicant
QUANTA SYSTEM, S.P.A.
via iv novembre,116
solbiate olona(va), 

IT

21058

Applicant Contact maurizio bianchi
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 06/07/2011
Decision Date 08/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No