The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Models 4000,4900,6000,8000,8900 Nd Yag 1700nd.
| Device ID | K894164 |
| 510k Number | K894164 |
| Device Name: | MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath 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 | 1989-06-15 |
| Decision Date | 1989-08-29 |