The following data is part of a premarket notification filed by Icn Pharmaceuticals, Inc. with the FDA for Cooltouch Nd:yag Laser System, Model Cooltouch, Cooltouch-ii Nd:yag Laser System, Model Cooltouch-ii.
| Device ID | K022817 |
| 510k Number | K022817 |
| Device Name: | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Edward F Smith |
| Correspondent | Edward F Smith ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-26 |
| Decision Date | 2002-11-22 |
| Summary: | summary |