Class Class I
EyeGility™ Inserter for Preloaded enVista IOLs (K242389)
Description
EyeGility™ Inserter for Preloaded enVista IOLs by Bausch & Lomb Incorporated, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK242389
Clearance Date2024-10-10
Clearance TypeTraditional
Product CodeMSS
Regulation Number886.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242389
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. EyeGility™ Inserter for Preloaded enVista IOLs (K242389) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019 |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Bausch & Lomb, Inc. | 2012 |
Trace the full predicate network for K242389
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.