THERMACOOL TC SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K030142
Device Name THERMACOOL TC SYSTEM
Original Applicant
THERMAGE, INC.
4058 point eden way
hayward, 
CA 
94545 -3721

Original Contact pamela m buckman
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 01/15/2003
Decision Date 02/03/2003
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