NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES


Device Classification Name

powered laser surgical instrument

510(k) Number K022181
Device Name NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
Original Applicant
LUMENIS, INC.
2400 condensa st.
santa clara, 
CA 
95051 -0901

Original Contact karen l baker
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/03/2002
Decision Date 10/01/2002
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