MODIFICATION TO PALOMAR LUX1540 HANDPIECE


Device Classification Name

powered laser surgical instrument

510(k) Number K073583
Device Name MODIFICATION TO PALOMAR LUX1540 HANDPIECE
Applicant
PALOMAR MEDICAL PRODUCTS, INC.
82 cambridge st.
burlington, 
MA 
01803

Applicant Contact sharon timberlake
Correspondent
PALOMAR MEDICAL PRODUCTS, INC.
82 cambridge st.
burlington, 
MA 
01803

Correspodent Contact sharon timberlake
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 12/20/2007
Decision Date 03/26/2008
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