COOLTOUCH MODELS NS 160 AND LC215 COOLIPO


Device Classification Name

powered laser surgical instrument

510(k) Number K072751
Device Name COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
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 09/27/2007
Decision Date 01/02/2008
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