Class Class II
LenSx Laser System (8065998162) (K243896)
Description
LenSx Laser System (8065998162) by Alcon Laboratories, Inc., an FDA 510(k) cleared ophthalmic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243896
Clearance Date2025-04-28
Clearance TypeTraditional
Product CodeOOE
Regulation Number886.4390
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243896
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. LenSx Laser System (8065998162) (K243896) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 |
Trace the full predicate network for K243896
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.