CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160


Device Classification Name

powered laser surgical instrument

510(k) Number K021848
Device Name CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 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 06/05/2002
Decision Date 09/03/2002
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