LUMENIS SELECTA DUET


Device Classification Name

powered laser surgical instrument

510(k) Number K021550
Device Name LUMENIS SELECTA DUET
Original Applicant
Ellex Medical Pty. Ltd.
7138 shady oak rd.
minneapolis, 
MN 
55344

Original Contact bill swaim
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/13/2002
Decision Date 08/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No