COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II


Device Classification Name

powered laser surgical instrument

510(k) Number K022817
Device Name COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
Original Applicant
ICN PHARMACEUTICALS, INC.
icn plaza
3300 hyland avenue
costa mesa, 
CA 
92626

Original Contact edward f smith
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 08/26/2002
Decision Date 11/22/2002
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