The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Models 4000,4900,6000,8000,8900, Luxus 6&100/1700.
| Device ID | K904444 |
| 510k Number | K904444 |
| Device Name: | MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Robert Milder |
| Correspondent | Robert Milder HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1990-12-13 |