SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K081181
Device Name SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
Applicant
CYNOSURE, INC.
5 carlisle road
westford, 
MA 
01886

Applicant Contact george cho
Correspondent
CYNOSURE, INC.
5 carlisle road
westford, 
MA 
01886

Correspodent Contact george cho
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/25/2008
Decision Date 05/05/2008
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