(QUANTA SYSTEM) SURGICAL LASER FIBERS

Device Classification Name

powered laser surgical instrument

510(k) Number

K131473

Device Name

(QUANTA SYSTEM) SURGICAL LASER FIBERS

Applicant

QUANTA SYSTEM, S.P.A.

via iv novembre,116

solbiate olona,

IT

21058

Applicant Contact

maurizio bianchi

Correspondent

QUANTA SYSTEM, S.P.A.

via iv novembre,116

solbiate olona,

IT

21058

Correspodent Contact

maurizio bianchi

Regulation Number

878.4810

Classification Product Code

GEX

Date Received

05/22/2013

Decision Date

10/24/2013

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