The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Ultraline Sterile Disposable Fiber.
| Device ID | K921807 |
| 510k Number | K921807 |
| Device Name: | ULTRALINE STERILE DISPOSABLE FIBER |
| 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 | 1992-04-15 |
| Decision Date | 1992-06-18 |