Class Class II
Pastelle (K250165)
Description
Pastelle by Wontech Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250165
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250165
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 (K250165) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241529 | Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. | 2024 |
| K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022 |
| K123293 | PASTELLE Q-SWITCHED ND: YAG LASER | Won Technology Co., Ltd. | 2013 |
Trace the full predicate network for K250165
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.