Class Class II
OPTOVISION Endoscopic Light Source Unit (K243591)
Description
OPTOVISION Endoscopic Light Source Unit by Optosurgical, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243591
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeOWN
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243591
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. OPTOVISION Endoscopic Light Source Unit (K243591) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AI... | Stryker | 2019 |
| K111342 | LIGHT GUIDE CABLE | Schott North America | 2011 |
Trace the full predicate network for K243591
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.