NOVUS SPECTRA


Device Classification Name

powered laser surgical instrument

510(k) Number K022327
Device Name NOVUS SPECTRA
Original Applicant
LUMENIS, INC.
3959 west 1820 south
salt lake city, 
UT 
84104

Original Contact kelly mohror
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/18/2002
Decision Date 10/16/2002
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