The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Ns 2500 Holmium Laser System.
| Device ID | K132607 |
| 510k Number | K132607 |
| Device Name: | NS 2500 HOLMIUM LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NEW STAR LASERS, INC. 2800 PLEASANT HILL RD. STE #175 Pleasant Hill, CA 94523 |
| Contact | Pamela M Buckman, Msn |
| Correspondent | Pamela M Buckman, Msn NEW STAR LASERS, INC. 2800 PLEASANT HILL RD. STE #175 Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-20 |
| Decision Date | 2014-03-21 |
| Summary: | summary |