Class Class II
SER Pen Carain MicroSystem (MP1209SP) (K241355)
Description
SER Pen Carain MicroSystem (MP1209SP) by Su-Ko Technologies, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241355
Clearance Date2024-10-09
Clearance TypeTraditional
Product CodeQAI
Regulation Number878.4430
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241355
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. SER Pen Carain MicroSystem (MP1209SP) (K241355) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022 |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | 2020 |
Trace the full predicate network for K241355
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.