Class Class II
Doctor Tecar Plus, Doctor Tecar Smart (K221043)
Description
Doctor Tecar Plus, Doctor Tecar Smart by Mectronic Medicale S.R.L., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221043
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodePBX
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221043
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. Doctor Tecar Plus, Doctor Tecar Smart (K221043) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 |
Trace the full predicate network for K221043
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.