The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Ns3000 Holmium Laser System.
| Device ID | K142286 |
| 510k Number | K142286 |
| Device Name: | NS3000 Holmium Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | New Star Lasers, Inc. 9085 Foothills Blvd. Roseville, CA 95747 |
| Contact | Natalie Vollrath |
| Correspondent | Pamela M. Buckman Buckman Company, Inc. 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2014-10-31 |
| Summary: | summary |