Class Class II
Pastelle Pro (K241527)
Description
Pastelle Pro by Wontech Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241527
Clearance Date2025-02-14
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241527
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. Pastelle Pro (K241527) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213567 | Medline UNITE Calcaneal Fracture Plating System | Medline Industries, LP | 2022 |
| K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022 |
| K202503 | Chrome | Quanta System Spa | 2020 |
| K161670 | Lucid Q-PTP / HWA 55 | Bison Medical Co, Ltd. | 2016 |
Trace the full predicate network for K241527
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.