AFFIRM CO2 AND AFFIRM CO2 HP


Device Classification Name

powered laser surgical instrument

510(k) Number K081424
Device Name AFFIRM CO2 AND AFFIRM CO2 HP
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 05/20/2008
Decision Date 03/19/2009
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