Class Class II
AQUABEAM Robotic System (AB2000) (K241952)
Description
AQUABEAM Robotic System (AB2000) by Procept Biorobotics, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241952
Clearance Date2024-09-30
Clearance TypeSpecial
Product CodePZP
Regulation Number876.4350
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241952
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. AQUABEAM Robotic System (AB2000) (K241952) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023 |
Trace the full predicate network for K241952
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.