COOLTOUCH ND: YAG LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K030453
Device Name COOLTOUCH ND: YAG LASER SYSTEM
Applicant
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville, 
CA 
95747

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

Correspodent Contact david r hennings
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/11/2003
Decision Date 05/12/2003
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