MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS


Device Classification Name

powered laser surgical instrument

510(k) Number K024093
Device Name MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
Original Applicant
LUMENIS, LTD.
2400 condensa st.
santa clara, 
CA 
95051

Original Contact anne worden
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/11/2002
Decision Date 06/19/2003
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