LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K030342
Device Name LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
Original Applicant
LUMENIS, LTD.
2400 condensa st.
santa clara, 
CA 
95051

Original Contact andrea l ruth
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/03/2003
Decision Date 07/17/2003
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