Class Class II
OptaBlate Radiofrequency (RF) Generator System (K250327)
Description
OptaBlate Radiofrequency (RF) Generator System by Stryker Instruments, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250327
Clearance Date2025-04-15
Clearance TypeSpecial
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250327
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. OptaBlate Radiofrequency (RF) Generator System (K250327) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microi... | Stryker Corporation | 2022 |
Trace the full predicate network for K250327
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.