Class Class II
ViVi® Toga Premium (K243522)
Description
ViVi® Toga Premium by Thi Total Healthcare Innovation GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243522
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeFYA
Regulation Number878.4040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243522
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. ViVi® Toga Premium (K243522) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HP... | Thi Total Healthcare Innovation GmbH | 2023 |
| K192194 | TotalShield II Surgical Helmet System | Zimmer Surgical, Inc. | 2019 |
Trace the full predicate network for K243522
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.