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 |