PRIMUS AESTHETIC PLATFORM


Device Classification Name

powered laser surgical instrument with microbeamfractional output

510(k) Number K103664
Device Name PRIMUS AESTHETIC PLATFORM
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
ONG  
Subsequent Product Code
GEX  
Date Received 12/16/2010
Decision Date 03/17/2011
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