The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Model 1000 Holmium Laser System.
| Device ID | K994273 |
| 510k Number | K994273 |
| Device Name: | MODEL 1000 HOLMIUM LASER SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859932006242 | K994273 | 000 |
| 00859932006235 | K994273 | 000 |
| 00859932006228 | K994273 | 000 |
| 00859932006211 | K994273 | 000 |
| 00859932006013 | K994273 | 000 |