PALOMAR ICON (TM) AESTHETIC SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K110907
Device Name PALOMAR ICON (TM) AESTHETIC SYSTEM
Applicant
PALOMAR MEDICAL TECHNOLOGIES, INC.
15 network drive
burlington, 
MA 
01803

Applicant Contact sharon timberlake
Correspondent
PALOMAR MEDICAL TECHNOLOGIES, INC.
15 network drive
burlington, 
MA 
01803

Correspodent Contact sharon timberlake
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received 03/31/2011
Decision Date 06/22/2011
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