Class Class II
OmniGuide RFID Surgical Laser Fibers (K230819)
Description
OmniGuide RFID Surgical Laser Fibers by Omni-Guide Holdings, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230819
Clearance Date2023-04-21
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230819
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OmniGuide RFID Surgical Laser Fibers (K230819) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022 |
Trace the full predicate network for K230819
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.