EVLT KIT AND D15PLUS AND D30PLUS DIODE


Device Classification Name

powered laser surgical instrument

510(k) Number K023543
Device Name EVLT KIT AND D15PLUS AND D30PLUS DIODE
Original Applicant
DIOMED, INC.
one dundee park, suites 5&6
po box 97
andover, 
MA 
01810

Original Contact samuel d wade
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/22/2002
Decision Date 12/02/2002
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