COOLTOUCH II
Powered Laser Surgical Instrument
NEW STAR LASERS, INC.
The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Cooltouch Ii.
Pre-market Notification Details
| Device ID | K002347 |
| 510k Number | K002347 |
| Device Name: | COOLTOUCH II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Contact | Donald V Johnson |
| Correspondent | Donald V Johnson NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-02 |
| Decision Date | 2000-08-17 |
Trademark Results [COOLTOUCH II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOLTOUCH II 76457863 3030766 Dead/Cancelled |
NEW STAR LASERS, INC. 2002-10-07 |
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