Class Class II
Ultravision2™ IonPencil (K240868)
Description
Ultravision2™ IonPencil by Alesi Surgical Limited, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240868
Clearance Date2024-08-12
Clearance TypeTraditional
Product CodePQM
Regulation Number878.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240868
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. Ultravision2™ IonPencil (K240868) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. | 2023 |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 2008 |
Trace the full predicate network for K240868
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.