Class Class II
DOLORCLAST Focused Shock Waves (K243279)
Description
DOLORCLAST Focused Shock Waves by E.M.S Electro Medical Systems S.A, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243279
Clearance Date2025-08-13
Clearance TypeTraditional
Product CodePZL
Regulation Number878.4685
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243279
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. DOLORCLAST Focused Shock Waves (K243279) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor... | Storz Medical AG | 2021 |
| K191961 | OrthoGold | Tissue Regeneration Technologies | 2019 |
Trace the full predicate network for K243279
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.