VISION ONE LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K111213
Device Name VISION ONE LASER SYSTEM
Applicant
LUMENIS INC.
3959 west 1820 south
salt lake city, 
UT 
84104

Applicant Contact jace r mclane
Correspondent
LUMENIS INC.
3959 west 1820 south
salt lake city, 
UT 
84104

Correspodent Contact jace r mclane
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/02/2011
Decision Date 07/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls