The following data is part of a premarket notification filed by Omni-guide Holdings, Inc. with the FDA for Lisa Laser Surgical Fibers.
| Device ID | K220189 |
| 510k Number | K220189 |
| Device Name: | LISA Laser Surgical Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Omni-Guide Holdings, Inc. 46 Manning Road Billerica, MA 01821 |
| Contact | Carlos O Acosta |
| Correspondent | Carlos O Acosta Omni-Guide Holdings, Inc. 46 Manning Road Billerica, MA 01821 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-04-29 |