CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160


Device Classification Name

powered laser surgical instrument

510(k) Number K022610
Device Name CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
Original Applicant
CLARUS MEDICAL, LLC.
1000 boone ave. north
minneapolis, 
MN 
55427

Original Contact tom barthel
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/06/2002
Decision Date 11/05/2002
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