LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS


Device Classification Name

powered laser surgical instrument

510(k) Number K030147
Device Name LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
Original Applicant
LUMENIS, LTD.
2400 condensa st.
santa clara, 
CA 
95051

Original Contact anna worden
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/15/2003
Decision Date 04/15/2003
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