The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Cooltouch; Cooltouch Ii; And Cooltouch Ct3 Nd:yag Laser System.
| Device ID | K040131 |
| 510k Number | K040131 |
| Device Name: | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NEW STAR LASERS, INC. 9085 FOOTHILLS BLVD. Roseville, CA 95747 |
| Contact | Donald V Johnson |
| Correspondent | Donald V Johnson NEW STAR LASERS, INC. 9085 FOOTHILLS BLVD. Roseville, CA 95747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-04-20 |
| Summary: | summary |