Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092)
Description
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT by Quanta System Spa, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241092
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. Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222221 | DEKA HELIX | El.En Electronic Engineering Spa | 2023 |
| K203441 | The Alma Hybrid Laser System | Alma Lasers , Ltd. | 2021 |
| K182669 | Youlaser CO2 | Quanta System Spa | 2018 |
Trace the full predicate network for K241092
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.