The following data is part of a premarket notification filed by Leoni Fiber Optics, Inc. with the FDA for Leoni Laser Fibers: Barefiber Disposable, Barefiber Reusable And Endoprobe Disposable.
| Device ID | K201171 |
| 510k Number | K201171 |
| Device Name: | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable And Endoprobe Disposable |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LEONI Fiber Optics, Inc. 209 Bulifants Blvd Williamsburg, VA 23188 |
| Contact | Martin Trapp |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2021-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851925007625 | K201171 | 000 |
| 00851925007526 | K201171 | 000 |
| 00851925007533 | K201171 | 000 |
| 00851925007540 | K201171 | 000 |
| 00851925007557 | K201171 | 000 |
| 00851925007564 | K201171 | 000 |
| 00851925007571 | K201171 | 000 |
| 00851925007588 | K201171 | 000 |
| 00851925007595 | K201171 | 000 |
| 00851925007601 | K201171 | 000 |
| 00851925007618 | K201171 | 000 |
| 00851925007519 | K201171 | 000 |