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 60,100&1700.
| Device ID | K902061 |
| 510k Number | K902061 |
| Device Name: | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Page, B.s. |
| Correspondent | Page, B.s. 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 | 1990-05-07 |
| Decision Date | 1990-07-10 |