Class Class II
Litho 60; Litho 100; Litho 150 (K242251)
Description
Litho 60; Litho 100; Litho 150 by Quanta System Spa, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242251
Clearance Date2024-09-03
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242251
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. Litho 60; Litho 100; Litho 150 (K242251) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201455 | Litho 150, Cyber Ho 150 | Quanta System Spa | 2020 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | 2020 |
| K161257 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | 2017 |
Trace the full predicate network for K242251
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.