Class Class II
MultiPulse TFL (K253100)
Description
MultiPulse TFL by Asclepion Laser Technologies GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK253100
Clearance Date2025-10-23
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K253100
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. MultiPulse TFL (K253100) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220426 | Fiber Dust PRO | Quanta System Spa | 2022 |
| K133891 | MULTIPULSE TM+1470 | Asclepion Laser Technologies GmbH | 2015 |
| K131081 | CYBER TM FAMILY | Quanta System Spa | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026 |
Trace the full predicate network for K253100
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.