PROFILE 1064 LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K023881
Device Name PROFILE 1064 LASER SYSTEM
Original Applicant
SCITON, INC.
845 commercial st.
palo alto, 
CA 
94303

Original Contact jay m patel
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/21/2002
Decision Date 06/13/2003
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