The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Cooltouch Varia Nd:yag Laser System.
| Device ID | K092964 |
| 510k Number | K092964 |
| Device Name: | COOLTOUCH VARIA ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NEW STAR LASERS, INC. 9085 FOOTHILLS BLVD. Roseville, CA 95747 |
| Contact | Natalie R Vollrath |
| Correspondent | Natalie R Vollrath 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 | 2009-09-25 |
| Decision Date | 2009-12-11 |
| Summary: | summary |