QUANTA SYSTEM DUOLITE


Device Classification Name

powered laser surgical instrument

510(k) Number K103539
Device Name QUANTA SYSTEM DUOLITE
Applicant
QUANTA SYSTEM, S.P.A.
via iv novembre,116
solbiate olona(va), 

IT

21058

Applicant Contact isabella carrer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/02/2010
Decision Date 01/20/2011
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