PROFILE 1320 LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K022381
Device Name PROFILE 1320 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 07/22/2002
Decision Date 10/18/2002
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