AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE


Device Classification Name

powered laser surgical instrument

510(k) Number K080006
Device Name AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
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 01/02/2008
Decision Date 02/28/2008
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