The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Mdls 4000/4900/6000/8000/8900/luxus 60/100 Nd:yag.
| Device ID | K903444 |
| 510k Number | K903444 |
| Device Name: | MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Donna Page |
| Correspondent | Donna Page 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 | 1990-07-27 |
| Decision Date | 1990-10-11 |