COOLTOUCH MODELS LC215 AND COOLLIPO


Device Classification Name

powered laser surgical instrument

510(k) Number K080163
Device Name COOLTOUCH MODELS LC215 AND COOLLIPO
Applicant
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville, 
CA 
95747

Applicant Contact natalie r vollrath
Correspondent
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville, 
CA 
95747

Correspodent Contact natalie r vollrath
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/23/2008
Decision Date 04/10/2008
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