REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200


Device Classification Name

powered laser surgical instrument

510(k) Number K110941
Device Name REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
Applicant
ALLMED SYSTEMS INC.
9232 klemetson drive
pleasanton, 
CA 
94588

Applicant Contact peter allen
Correspondent
ALLMED SYSTEMS INC.
9232 klemetson drive
pleasanton, 
CA 
94588

Correspodent Contact peter allen
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/04/2011
Decision Date 02/19/2013
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