Class Class II
LGO-Surgical Laser Fibers (K243147)
Description
LGO-Surgical Laser Fibers by Light Guide Optics International , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243147
Clearance Date2024-12-21
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243147
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. LGO-Surgical Laser Fibers (K243147) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202702 | FLARE Single-Use Surgical Laser Fiber | Realton (Suzhou) Medical Technology... | 2021 |
| K200234 | Surgical laser fibers | Quanta System Spa | 2020 |
Trace the full predicate network for K243147
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.