ASA ‘MPHI FAMILY DIODE LASER


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K111901
Device Name ASA ‘MPHI FAMILY DIODE LASER
Applicant
CYNOSURE, INC.
5 carlisle road
westford, 
MA 
01886

Applicant Contact anthony burns
Correspondent
CYNOSURE, INC.
5 carlisle road
westford, 
MA 
01886

Correspodent Contact anthony burns
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 07/05/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No