ILUMINAGE DIODE LASER


Device Classification Name

light based over the counter wrinkle reduction

510(k) Number K111454
Device Name ILUMINAGE DIODE 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
OHS  
Subsequent Product Code
GEX  
Date Received 05/25/2011
Decision Date 07/05/2012
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